MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 HA ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-11-054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/05/2021
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
Revision case due to infection on (b)(6) 2021.The case had occurred and all implants removed due to infection being present.Competitor implants cemented insitu for 1st stage revision.
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: 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
Additional information received indicated that there was no surgical delay and the affected side of the patient was the left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination 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.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: PINNACLE 100 HA ACET CUP 54MM
• 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: 12025680
• Report Number: 1818910-2021-12999
• Device Sequence Number: 11847002
• Product Code: LPH
• UDI-Device Identifier: 10603295009078
• UDI-Public: 10603295009078
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 06/06/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1217-11-054
• Device Catalogue Number: 121711054
• Device Lot Number: HY2841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2021
• Supplement Date Received by Manufacturer: 07/04/2021; 07/28/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/10/2021; 07/29/2021
• 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 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; CORAIL AMT COLLAR SIZE 11; DELTA CER HEAD 12/14 36MM +5; PINNACLE 100 HA ACET CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention