MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-20-056
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
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
Total hip replacement - acetabulum reamed to 55 mm and trialed with a 56 cup.Trial was very stable and hence decision to open actual implant.Opened 56 mm porocoat multihole but the cup felt small and loose within the acetabulum, when measured the diameter of actual implant using caliper, it showed 55 mm in diameter.Decided to open another 56 mm gription coating cup and diameter when measured was 56.5 mm and fit well and stable within acetabulum.
Event or Problem Description
Additional information received indicated that the event happened during a primary surgery.
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:  patient code: no code available (3191) is used to capture prolonged surgery and insufficient information.Remove not applicable code.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 is unable to confirm the reported observation.The device is found to meet the geometry called out on drawing.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 dhr has been reviewed and no deviations or anomalies were found.

• Brand Name: PINNACLE MULTIHOLE II CUP 56MM
• 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: 10636994
• Report Number: 1818910-2020-21652
• Device Sequence Number: 11401735
• Product Code: KWA
• UDI-Device Identifier: 10603295009641
• UDI-Public: 10603295009641
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K073504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-20-056
• Device Catalogue Number: 121720056
• Device Lot Number: HD0867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 12/08/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/16/2020; 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1