MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 28MM +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-059
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)
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
It was reported that on (b)(6) 2008, the primary surgery was performed with the stem.On (b)(6) 2017, the first revision surgery was performed due to the suspicion of armd replacing cup (stryker¿s product) and head (unk) with new cup (other company¿s product) and head (152190059/d15080899).The second revision surgery will be performed due to infection on (b)(6) 2021 replacing the stem, head and cup (other company¿s product).We create only this pc because it is unknown what implants had been used in the primary surgery and what company manufactured the implants.The stem (134522000/b4taa1000) implanted in the primary surgery and the head (152190059/d15080899) implanted in the first revision are the j&j product.No further information is available.On (b)(6), the secondary revision surgery was performed.In the revision, the cup (stryker's product) and stem was removed, and the cement and cement mold were used and the revision surgery was completed.
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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: 9/10 COCR HEAD 28MM +3
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11737140
• Report Number: 1818910-2021-08988
• Device Sequence Number: 14370756
• Product Code: JDI
• UDI-Device Identifier: 10603295276647
• UDI-Public: 10603295276647
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 04/13/2021

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: 1521-90-059
• Device Catalogue Number: 152190059
• Device Lot Number: D15080899
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: 9/10 COCR HEAD 28MM +3; AML A PLUS 11.0 MM; COMPETITOR; 9/10 COCR HEAD 28MM +3; AML A PLUS 11.0 MM; COMPETITOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR