MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ELITE PLUS LPW CUP 28/53; MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS

Model Number	9651-28-053
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
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
Original total hip replacement (c-stem) was conducted (b)(6) 2005 at (b)(6) hospital.Today ((b)(6) 2021), the elite plus lpw cup was removed and a competitor cup implanted.The original elite head was also removed and a new one implanted.Patient demographics: unknown.Reason for revision: instability.Further patient details and operation notes unavailable.
Event or Problem Description
Additional information received indicated that the affected side 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 : 45 parts were manufactured per specification.3 parts were scrapped due to marred faces.
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 manufacturing record evaluation was performed for the finished device yem-01 number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.
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 manufacturing record evaluation was performed for the finished device yem-01 number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.45 parts were manufactured per specification.3 parts were scrapped due to marred faces.

• Brand Name: ELITE PLUS LPW CUP 28/53
• Common Device Name: MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11463759
• Report Number: 1818910-2021-04950
• Device Sequence Number: 4188790
• Product Code: JDI
• UDI-Device Identifier: 10603295318569
• UDI-Public: 10603295318569
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 02/25/2021

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: 9651-28-053
• Device Catalogue Number: 965128053
• Device Lot Number: YEM-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 12/14/2021; 05/17/2022
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 05/06/2021; 12/15/2021; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ELITE MODULAR HD 28MM +3; ELITE PLUS LPW CUP 28/53
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male