MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN DP REVSN W/GRIPTION 68MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-17-068
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	11/09/2020
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
It was reported that the patient was revised due instability and loosed cup at the bone to implant interface.Don¿t know when or where was implanted prior, don¿t have access to lot #s, and original implant date unknown.No surgical delay.Doi: unknown; dor: (b)(6) 2020; right hip.
Additional 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 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 a device history record (dhr) review, was not possible because the required lot code was not provided.H10 additional narrative:.

• Brand Name: PINN DP REVSN W/GRIPTION 68MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10927788
• Report Number: 1818910-2020-25791
• Device Sequence Number: 19904157
• Product Code: LPH
• UDI-Device Identifier: 10603295009528
• UDI-Public: 10603295009528
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K071784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 1217-17-068
• Device Catalogue Number: 121717068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: ALTRX NEUT 36IDX62OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR