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	Degraded (1153)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
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 an unknown date, about 10 years before now, the primary surgery was performed with the head and cup in question.On an unknown date, the revision surgery was performed due to unknown reason.In the revision, only the head and cup were removed, and stem was left in the patient because the stem was not loose.The head was removed easily.The surrounding tissue was not discolored.The head neck junction part was slightly discolored to black at the distal taper part.The black material adhered to the removed head.The surgeon suspected the armd and requested the investigation of the component analysis.No further information is available.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.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.H10 additional narrative: added: d9.Corrected: h3.

• 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: 11706012
• Report Number: 1818910-2021-08452
• Device Sequence Number: 11517679
• 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
• 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): 04/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1521-90-059
• Device Catalogue Number: 152190059
• Device Lot Number: 3167095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 06/30/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/06/2021; 07/01/2021
• 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: SELF CENT HIP 46X28 BRN; UNKNOWN HIP FEMORAL STEM; SELF CENT HIP 46X28 BRN; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention