MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-054

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191); Unspecified Musculoskeletal problem (4535)

Event Date 08/01/2019

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 primary tha was on (b)(6) 2016 by dr.(b)(6) at (b)(6).Revision tha was on (b)(6) 16 by dr.(b)(6) at (b)(6) (head and liner revised, acetabular screw removed).The patient came to the orthopedic urgent care located in dr.(b)(6) clinic complaining of pain.X-rays revealed what appeared to be a failure at the interface of the acetabular shell and poly liner.If accurate, this would be the second such dissociation for this patient since the original surgery in 2016.The poly and head were revised in 2018 for the same indication.The patient is adamant that this is a failure on the part of depuy and has indicated that she will be seeking legal remedy against depuy.Revision surgery is indicated and will be performed by dr.(b)(6) (date to be determined).The patient has indicated that her preference would be that no depuy products are to be used in the revision.Please bring this to the attention of legal.3rd revision.Doi: (b)(6) 2018.Dor: (b)(6) 2019.Left hip.

Manufacturer Narrative

(b)(4).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.Lot: 704087.A device history record (dhr) review was performed on (b)(4).No related deviations or anomalies were identified.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).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).No code available us for device revision or replacement.

Event Description

Pfs alleged weakness.After review of medical records, it was indicated that the patient notice squeaking in her hip.Radiographs were obtained revealing that the acetabular liner had dislodged.The patient was then revised to addressed recurrent failure of left total hip arthroplasty with recurrent disassociation of acetabular polyethylene liner.Operative notes indicated small amount of black metallic staining in the synovium and soft tissue and scar tissue was removed.The ceramic femoral head showed evidence of significant wear and scratching from the acetabular component.The liner was deformed in an oblong elongated manner.

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.E3 initial reporter occupation: lawyer.

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.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device 121732054, lot 704087, and no non-conformances / manufacturing irregularities were identified.Device history review: a device history record (dhr) review was performed on (b)(4).No related deviations or anomalies were identified.Re-captured h6 (clinical, impact and medical device problem codes).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.An x-ray review was performed and confirmed the reported allegation.The investigation found the head and cup component making direct contact suggesting the liner has disassociated form the cup.It is reasonable to confirm audible sound based on the investigation findings.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a device history record (dhr) review was performed on lot# 704087.No related deviations or anomalies were identified.Device history review : a device history record (dhr) review was performed on lot# 704087.No related deviations or anomalies 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.Corrected: h6 (clinical code).

Event Description

Medical records were received and stated the following: on (b)(6) 2019, the patient had a left total hip revision to address the recurrent failure of the left hip with recurrent dissociation of the acetabular polyethylene liner.Preoperative radiographs revealed an asymmetric position of the femoral head within the acetabulum consistent with dissociation of the poly liner.Prior to surgery, the patient experienced pain, limping, clicking, and weakness in the left hip.During the procedure, the surgeon observed a small amount of black metallic staining in the synovium of the soft tissue, and the liner had disassociated from the cup.The ceramic femoral head showed evidence of significant wear and scratching from the acetabular component.The acetabular cup, liner, and femoral head were revised.Competitor acetabular components along with depuy ceramic femoral head were implanted during this procedure.

• Brand Name: PINN SECTOR W/GRIPTION 54MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8922058
• MDR Text Key: 155253294
• Report Number: 1818910-2019-102007
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010319
• UDI-Public: 10603295010319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/01/2019

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: 1217-32-054
• Device Catalogue Number: 121732054
• Device Lot Number: 704087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 08/23/2019; 03/30/2020; 07/20/2021; 02/09/2023; 03/30/2023; 04/25/2023
• Supplement Dates FDA Received: 08/26/2019; 04/09/2020; 07/28/2021; 02/10/2023; 04/19/2023; 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• 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: ALTRX +4 10D 36IDX54OD; CORAIL2 LAT COXA VARA SIZE 12; DLT TS CER HD 12/14 36MM +8.5; DLT TS CER HD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX45MM; UNKNOWN HIP IMPLANT (SCREW); DLT TS CER HD 12/14 36MM +8.5; UNKNOWN HIP IMPLANT (SCREW)
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female