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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/21/2022
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) 2003, the patient underwent the primary surgery via tha of left with aml-plus/duralock implants in question.The surgery was completed successfully without any surgical delay.After the surgery, the patient has frequent dislocations last 10 years.A revision surgery is planed soon.No further information is available.Doi: (b)(6) 2003; dor: (b)(6) 2022; affected side: unknown.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary = > the device associated with this report was not received for examination.All available x-rays and photographs were reviewed and the complaint is confirmed due to an implant dislocation was observed.Additionally, based on the evidence it appears that the acetabular cup is positioned with more anteversion angles than is recommended by depuy.This condition does not represent a device failure depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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).A manufacturing records evaluation (mre) was not performed.Added: b5.
Event or Problem Description
Additional information received.The affected side involved in this event is the left hip.

• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15699171
• Report Number: 1818910-2022-21616
• Device Sequence Number: 8229377
• 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 Implanted Year: 2003
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 1521-90-051
• Device Catalogue Number: 152190051
• Device Lot Number: 1070117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2002
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9/10 COCR HEAD 22.225MM -3; AML A PLUS 12.0 MM; CB DURALOC 10DEG LINER 50MM; DURALOC 1200 SERIES 50MM OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown