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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Renal Failure (2041); Joint Dislocation (2374); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
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
This pc is related to (b)(4).This pc reports about the second dislocation and osteolysis.It was reported that on an unknown date, 1991, the patient underwent the tha surgery with unknown cup and stem.After the surgery, on an unknown date, the loosening of the cup and stem occurred, and the first revision surgery was performed on (b)(6) 2010.After the surgery, the patient dislocated on an unknown date, 2016.The surgeon commented that ct can show widespread tumorous appearance around the hip.Osteolysis can also be confirmed.It may be a pseudotumor symptom due to cobalt chromium.Currently, reoperation is postponed due to decreased renal function.On an unknown date 2021, the patient dislocated again and x-ray showed osteolysis of the pelvis and femur.The second revision surgery will be performed if necessary and the liner and cup will be replaced.No further information is available.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.Visual examination of the provided x-ray images confirmed the reported dislocation.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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 : a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• 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: 12159923
• Report Number: 1818910-2021-15050
• Device Sequence Number: 19705696
• 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: 2010
• 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): 06/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1521-90-059
• Device Catalogue Number: 152190059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/29/2021
• 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; SOLUTION A 8IN BOW 16.5 RT; 9/10 COCR HEAD 28MM +3; SOLUTION A 8IN BOW 16.5 RT
• Patient Age: 64 YR