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	1521-90-057
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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) 2005, the primary surgery was performed via tha with the stem, head and liner in question.On (b)(6) 2021, the patient was urgently transported to the hospital and it was found that the head and stem disassociated secondary to wear on the stem.In the revision, the surgeon removed the head, washed the stem, replaced the liner with the new one and implanted the new head.The surgeon commented that the dislocation improved, and the range of motion stabilized.The surgery was completed successfully without any surgical delay.No further information is available.Doi: (b)(6) 2005.Dor: (b)(6) 2021; unknown 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.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: 11496713
• Report Number: 1818910-2021-05094
• Device Sequence Number: 2965406
• Product Code: JDI
• UDI-Device Identifier: 10603295276623
• UDI-Public: 10603295276623
• 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: 2005
• 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): 02/27/2021

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: 1521-90-057
• Device Catalogue Number: 152190057
• Device Lot Number: 1882697
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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.; ENDURON 10D 50OD X 28ID.; REPLICA A STEM 10.0MM.; UNK HIP LOCKING RING.; 9/10 COCR HEAD 28MM -3; ENDURON 10D 50OD X 28ID; REPLICA A STEM 10.0MM; UNK HIP LOCKING RING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR