MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 26MM -3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-054
Health Effect - Clinical Code	Joint Dislocation (2374)
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 the primary surgery was performed on an unknown date at another hospital ((b)(6) hospital) via tha.The patient had underwent 1st, 2nd and 3rd revision surgery.The dates of 1st and 2nd revision surgery was unknown, the 3rd revision surgery was performed on (b)(6) 2004.The explanted implants were unknown in all revision surgery.One of those revision surgeries includes a debridement, however, detail information of all revision surgeries were unknown.It was reported that the 4th revision surgery was performed on (b)(6) 2021 by replacing the cup (manufactured by zimmer biomet) and the head due to repetitive dislocation.Consider the patient's age and activity, the surgeon remained the stem, by replacing the head, got the offset length (implanted new head is 36mm/+3 size).The surgery was completed without any surgical delay.The patient infected covid-19.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : as no other reports of any kind were identified over the previous five year period it is reasonable there was no error in the manufacturing or material of this product/lot combination that would be a contributing factor in the reported allegations.It is also noted the device was used off-label.A manufacturing records evaluation (mre) was not performed.

• Brand Name: 9/10 COCR HEAD 26MM -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: 11179010
• Report Number: 1818910-2021-01301
• Device Sequence Number: 11491892
• Product Code: JDI
• UDI-Device Identifier: 10603295276593
• UDI-Public: 10603295276593
• 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: 2004
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 1521-90-054
• Device Catalogue Number: 152190054
• Device Lot Number: 1198815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/22/2021
• 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: CUP (ZIMMER BIOMET)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 59