MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-36-056
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent an acetabular revision of her primary hip on the (b)(6) 2021 (initial component was a stryker cup and stem.Patient had a fall resulting in the need for the primary revision).The patient has been complaining of pain and squeaking in her hip for a few weeks, so the surgeon did a follow up x-ray and noted that the liner of the pinnacle cup used in the revision in 2021 had failed and that the patient required re-revision of the head and liner.Upon opening the patient, it was noted that the pinnacle liner had dissociated from the pinnacle shell and that the head was articulating on the inside of the shell.There were signs of metalosis in the tissues immediately around the hip joint, there were also signs of wear on the femoral head and acetabular shell.The surgeon elected to revise the femoral head (stryker implant) as well as replace the pinnacle liner with a new one.Doi: (b)(6) 2021.Dor: (b)(6) 2022.Unknown hip.
Additional 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 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.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
Affected side: left hip.
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 - the device associated with this complaint was not returned for examination.The photo investigation and x-ray review found enough evidence to confirm the reported allegation.The position of the head on the x-rays and the liner missing 3 ards on the photograph, indicates disassociation.It is reasonable to expect noise/squeaking due to the disassociation.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 - 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.H10 additional narrative: added: d10 and h6 (clinical and device codes).

• Brand Name: PINN MAR NEUT 36IDX56OD
• 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15293165
• Report Number: 1818910-2022-16612
• Device Sequence Number: 7222550
• Product Code: LPH
• UDI-Device Identifier: 10603295014461
• UDI-Public: 10603295014461
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 08/25/2022

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: 1219-36-056
• Device Catalogue Number: 121936056
• Device Lot Number: 9453596
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 11/03/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/07/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2020
• 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: PINN MAR NEUT 36IDX56OD.; PINNACLE CUP.; STRYKER .; STRYKER HEAD.; UNK HIP FEMORAL HEAD CERAMIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female