MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL HIP BALL 28MM +8; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1018-14-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); No Code Available (3191)
Date of Event	08/06/2020
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 this patient had her hip replaced approximately 20 plus years ago and came to the er at (b)(6) because she was not feeling well and had a fever of 103 according to surgeon.She did not remember where she had her hip replaced or who did the surgery.Xrays revealed that the stem was a 5/8 aml stem with a large taper hip ball and a competitor cup.Patient also had an infection.The surgeon did a thorough i&d and exchanged our hip ball.The aml stem was left in situ.No information is available for the aml lot number and no lab reports available.Affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Mwr-13082020-0000784401, is being retracted as it was submitted in error.There are no allegations of patient consequence or injury, or device malfunction, that are related to depuy devices or procedure.

• Brand Name: TOTAL HIP BALL 28MM +8
• Common Device Name: LARGE TAPER 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: 10432098
• Report Number: 1818910-2020-18466
• Device Sequence Number: 16879469
• Product Code: JDI
• UDI-Device Identifier: 10603295001355
• UDI-Public: 10603295001355
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K860701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1018-14-000
• Device Catalogue Number: 101814000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 07/22/2021
• 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: STRYKER VIRALOCK CUP.; TRI-LOCK BPS SZ 4 HI OFFSET.; STRYKER VIRALOCK CUP; TRI-LOCK BPS SZ 4 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 113