MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 22.225MM -3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-051
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 about 20years before now, on an unknown date, the primary surgery was performed via tha with the liner, head and wire in question.On an unknown date, it was confirmed that the wire, which was used around the femur, had been broken, and the pus was spreading, and the patient felt pain due to this event on the right side.On (b)(6) 2021, the revision surgery will be performed replacing the liner and head.On (b)(6) 2021, the revision surgery was performed.Before entering the room, the patient was already bleeding at her femoral shaft part, and her femur was covered with gauze.After the surgeon made an incision, he cut the cables and removed them with a pliers.And he removed the head and tried to remove the liner, but he had difficulty in removing the liner with the removal instruments.Finally, he broke the liner with a chisel and remove the liner.He implanted new head and liner and closed the incision.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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: 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 22.225MM -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: 11723824
• Report Number: 1818910-2021-08649
• Device Sequence Number: 3946609
• Product Code: JDI
• UDI-Device Identifier: 10603295276562
• UDI-Public: 10603295276562
• 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 Explanted Year: 2021
• 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
• Report Date (Section B): 04/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1521-90-051
• Device Catalogue Number: 152190051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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: CB DURALOC 10DEG LINER 48MM; UNK CABLE/WIRE; UNKNOWN HIP ACETABULAR CUP; CB DURALOC 10DEG LINER 48MM; UNK CABLE/WIRE; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention