MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-12-052
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	01/01/2020
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
Surgeon revising corail pinnacle for dislocation.Insitu was a ceramic liner which would not disassociate from the pinnacle sector cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).
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.Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: PINN SECTOR HA ACET CUP 52MM
• 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: 9779341
• Report Number: 1818910-2020-06608
• Device Sequence Number: 2650416
• Product Code: KWA
• UDI-Device Identifier: 10603295009160
• UDI-Public: 10603295009160
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/11/2020

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: 1217-12-052
• Device Catalogue Number: 121712052
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/26/2020; 03/25/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/12/2020; 04/01/2020
• 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: APEX HOLE ELIM POSITIVE STOP; EA DELTA CER INSERT 36IDX52OD; PINN SECTOR HA ACET CUP 52MM; UNKNOWN HIP FEMORAL HEAD; APEX HOLE ELIM POSITIVE STOP; EA DELTA CER INSERT 36IDX52OD; PINN SECTOR HA ACET CUP 52MM
• Outcome Attributed to Adverse Event: Required Intervention