MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-32-148

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191); Unspecified Musculoskeletal problem (4535); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient was experiencing pain in her right hip due to a flipped pinnacle altrx liner.An acetabular revision was performed where a pinnacle cup and altrx liner were explanted.The pinnacle cup and altrx liner that was explanted will be shipped back to corporate for further inspection.Doi: (b)(6) 2016; dor: (b)(6) 2019; right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In addition to what previously alleged, patient alleges walking difficulty, metal portions of implant to create friction releasing metal into the tissue, muscles and bloodstream.Squeaking noise that appeared to emanate from hip, grinding and cracking sounds, broken hip implant and polyethyline wear.Doi: (b)(6) 2016, dor: (b)(6) 2019, right hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 clinical code; appropriate term/ code not available (e2402) is used to capture joint injury (e20).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.

Manufacturer Narrative

Product complaint #
=
> pc(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a4, b5, b7, d10, h6 (clinical code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.

Event Description

After review of medical record, patient was revised to address failed right total hip arthroplasty.Patient complained limited range of motion and discomfort on internal rotation.There is eccentric positioning of the femoral head within the acetabulum consistent with polyethylene wear.Revision notes stated there was abundant amount of metallosis and large pseudotumor.The liner was clearly broken and disassociated from the cup.Cup, liner and metal head were removed.There was impingement anteriorly and right leg lengths were a couple millimeters short compared to contralateral side.Doi: (b)(6) 2016 dor: (b)(6) 2019 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (nc search) was performed for the finished device 122132148 , lot 505975, and no non-conformances / manufacturing irregularities were identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device 122132148 , lot 505975, and no non-conformances / manufacturing irregularities were identified.

Event Description

After review of litigation records, on 11/11/2019, pathology report of tissue samples taken demonstrated evidence of chronic lymphohistiocytic inflammation and foreign body giant cell reaction and large amount of black discoloration suggestive of polyethylene.As a direct and proximate result, the patient sustained serious personal injuries including suffering, emotional distress and mental anguish.

Manufacturer Narrative

Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (medical device problem code).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was not able to confirm the complaint since no signs of an implant disassociation or wear were observed.Also, no fractures were able to be identified from the provided evidence.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device (b)(6) , lot 505975, and no non-conformances / manufacturing irregularities were identified.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received: on (b)(6) 2016, the patient had a right total hip arthroplasty to address severe degenerative arthritis.A pinnacle cup was implanted along with a competitor stem.(b)(6) 2019, the patient had a right total hip revision to address failed right total hip arthroplasty.Due to right hip pain with limiting functional mobility, and squeaking noise from the right hip.During the procedure, the surgeon observed metallosis and a large pseudotumor.The surgeon reported the liner had clearly broken (fractured) and had disassociated from the cup.The cup/liner/and femoral head were revised.Competitor components were implanted during this procedure.(b)(6) 2019, discharge summary noted the patient required two 500 ml boluses of saline and a postoperative transfusion of 1 unit of packed red blood cells for continued hypotension post-surgery.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b6 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ALTRX +4 10D 32IDX48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9412526
• MDR Text Key: 185176499
• Report Number: 1818910-2019-120311
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016151
• UDI-Public: 10603295016151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1221-32-148
• Device Catalogue Number: 122132148
• Device Lot Number: 505975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 12/19/2019; 12/30/2020; 04/08/2021; 02/08/2022; 10/28/2022; 11/22/2022; 03/09/2023; 04/27/2023; 05/26/2023; 07/18/2023; 08/01/2023; 09/05/2023; 10/12/2023
• Supplement Dates FDA Received: 12/24/2019; 01/13/2021; 04/21/2021; 02/09/2022; 11/09/2022; 11/22/2022; 03/09/2023; 05/16/2023; 06/12/2023; 07/25/2023; 08/07/2023; 09/12/2023; 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; COMPETITOR STEM; PINNACLE 100 ACET CUP 48MM; PINNACLE 100 ACET CUP 48MM; PINNACLE 100 ACET CUP 48MM; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 95 KG