MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD; METAL ACETABULAR LINER

Model Number 1218-87-354

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Joint Dislocation (2374); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Pinnacle mom litigation record received.Patient alleges elevated metal ion, suffered injury to muscle and tissue, suffered aditional scar tissue formation, pain, fluid collection, pseudotumor, tissue destruction, metal wear, metal poisoning, loss of enjoyment of life, and limitation of daily activities, disability, and emotional distress.Doi: (b)(6) 2010.Dor: unk.(right hip).

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 (mre) will not be performed since mom systems are obsolete.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.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 - the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.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: b5, b6, h6 (clinical and medical device problem codes), g4 (pma) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3.

Event Description

Medical records were received: medical records report closed reduction dislocation.Tendinosis/tendinopathy with subtle partial tears of the hamstring origin noted bilaterally.Doi: (b)(6) 2010 dor: (b)(6) 2023 right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Update:30-aug-2023.Update aug 29, 2023 received did not have any additional details to be added in investigation.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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 that 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.H11 additional narrative: added : b5, b6, b7 corrected: d4 primary udi number, h6 health effect - impact code 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: it was mentioned on page 116 that patient had a dislocation reduction on (b)(6) 2023 and not (b)(6) 2023 that was mentioned on file (b)(4) medical records ad 17 aug 2023.Please see below findings: 1) updated event description: on (b)(6) 2023, patient underwent right revision, hip replacement, head and linear exchange due to failed total hip arthroplasty and other mechanical complication of internal right hip prosthesis.Doi: on (b)(6) 2010, dor: on (b)(6) 2023: right hip.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: METAL ACETABULAR LINER
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14269257
• MDR Text Key: 290663437
• Report Number: 1818910-2022-07933
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295012382
• UDI-Public: (01)10603295012382(17)150215(10)3078756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/02/2022

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 Expiration Date: 02/15/2015
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 3078756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 05/04/2022; 03/01/2023; 03/09/2023; 08/21/2023; 08/30/2023; 08/05/2024
• Supplement Dates FDA Received: 05/06/2022; 03/08/2023; 03/09/2023; 08/29/2023; 08/30/2023; 08/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5; CORAIL2 LAT COXA VARA SIZE 13; PINN SECTOR W/GRIPTION 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male