MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 28IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-28-148
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Insufficient Information (4580)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Clinical adverse event received for liner failure - poly wear.Event is serious and is considered moderate.Event is definitely related to device and definitely not related to procedure.On (b)(6) 2021, the patient underwent a bilateral hip revision.Right side: the depuy femoral head and acetabular liner were revised.The patient was experiencing pain.There was evidence of poly wear involving the acetabular liner, delamination of the poly liner, and foreign body synovitis.The head and liner were revised with depuy products.Date of implant: (b)(6) 2002; date of event: (b)(6) 2019; date of revision: (b)(6) 2021; (right hip).Treatment: revision of the poly liner and head.
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.
Event or Problem Description
On (b)(6) 2021, the patient underwent a bilateral hip revision.Right side: the depuy femoral head and acetabular liner were revised.The patient was experiencing pain.There was evidence of poly wear involving the acetabular liner, delamination of the poly liner, and foreign body synovitis.The head and liner were revised with depuy products.There were no indicated intra-operative complications.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Although not returned poly material wear after approximately 21 years implanted would not be unreasonable to have identified.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 : although not returned poly material wear after approximately 21 years implanted would not be unreasonable to have identified.Product error is not suspected.Mre not performed.

• Brand Name: PINN MAR +4 10D 28IDX48OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12253428
• Report Number: 1818910-2021-16621
• Device Sequence Number: 11680080
• Product Code: LPH
• UDI-Device Identifier: 10603295013457
• UDI-Public: 10603295013457
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2021

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: 1219-28-148
• Device Catalogue Number: 121928148
• Device Lot Number: U56A71004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 07/20/2021; 08/18/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/09/2021; 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PINN MAR +4 10D 28IDX48OD; UNK FEMORAL HEAD; PINN MAR +4 10D 28IDX48OD; UNK FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 57