MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-052
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Hcp is reporting a second revision for patient because of disassociation of liner from pinnacle cup.During this revision pinnacle liner and cup were revised.Doi: 2011; dor: (b)(6) 2021; left hip.
Event or Problem Description
It is indicated the patient underwent a primary left hip arthroplasty with implantation of depuy products.Implanted products are found on page 1 of the attached medical information.It is indicated on (b)(6) 2019, the patient underwent a revision due to left hip disassociation of the cup and liner, possible infection, and detection of polyethylene and metal abrasion.The ceramic head and poly liner were revised.Post-operative microbiology reports indicated no evidence of infection.Operative note not available at the time of review.Event is captured on (b)(4).A second revision occurred on (b)(6) 2021 to address disassociation of the cup and liner, pain, and grinding.Product information can be found on page 1 of the attached medical records.Operative note not available at the time of review.Event is captured on (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).This device was also subject of (b)(4) as the patient experienced adverse events on different days with the same device.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 that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device found evidence to support disassociation of the liner from the cup while implanted.This device was manufactured on 07-jun-2019.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 07-jun-2019.3) any anomalies or deviations identified in dhr: scrap: 1 part from this lot was scrapped.Scrap code a001: this concerns black spot/embedded particle identified in material.There is no correlation between this scrap reason and the failure mode of the complaint as the scrap was a cosmetic defect.4) expiry date: 31-may-2024.5) ifu reference: 090200701.

• Brand Name: PINN MAR NEUT 32IDX52OD
• Common Device Name: 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 dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12432425
• Report Number: 1818910-2021-19357
• Device Sequence Number: 11618182
• Product Code: LPH
• UDI-Device Identifier: 10603295013907
• UDI-Public: 10603295013907
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1219-32-052
• Device Catalogue Number: 121932052
• Device Lot Number: 9179922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021; 09/30/2021; 11/04/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/28/2021; 10/03/2021; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; DLT TS CER HD 12/14 32MM +5; DLT TS CER HD 12/14 32MM +5; PINNACLE 100 ACET CUP 52MM; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR CUP PINNACLE; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP ACETABULAR LINERS; UNK HIP ACETABULAR CUP PINNACLE; UNKNOWN HIP ACETABULAR LINERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 87 KG