MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-31-048
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent total hip revision for a pinnacle liner dissociation.Liner and cup were removed and revised to dual mobility construct.Doi: (b)(6) 2012, dor: (b)(6) 2021, affected side: unknown hip.
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.
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.H10 additional narrative: added: b5 and h6 (patient).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
A.No lot numbers available.B.Duration of delay was minimal, but this procedure was due to a product failure.C.Right hip.D.Nothing broke.3.The stem was not revised.-----------on (b)(6) 2012, the patient had a right total hip arthroplasty to address osteoarthritis of right hip.Depuy components were used during this procedure.The patient was implanted with a pinnacle cup 48 od 32id and a poly liner.No part number/lot numbers were provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this complaint was received for examination.The photo investigation can confirm the reported allegation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: PINN 100 W/GRIPTION 48MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 13205473
• Report Number: 1818910-2022-00510
• Device Sequence Number: 19970831
• Product Code: KWA
• UDI-Device Identifier: 10603295010180
• UDI-Public: 10603295010180
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1217-31-048
• Device Catalogue Number: 121731048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 01/19/2022; 02/14/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 01/26/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ALTRX NEUT 32IDX48OD; DELTA CER HEAD 11/13 32MM +0; PINN 100 W/GRIPTION 48MM; SROM*STM ST,36+8L NK,18X13X160
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female