MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL HIP BALL 28MM +8; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1018-14-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/03/2018
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
Case logged to capture additional revision associated with (b)(4).The patient was revised for dislocation.
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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 : (b)(4) parts were manufactured per specification.1 part was rejected at op 143 due to a damaged sphere of the bore.H10 additional narrative:  added: b5.
Event or Problem Description
A.Was there a surgical delay because of this event? if yes, what was the duration of the delay? as this was a revision surgery, there was no surgical delay.B.What is the affected side involved in this event? please refer to additional event information (b)(4).(b)(4) - call log with (b)(6) 03/06/2021: he was unable to confirm which was the affected side, however he advised that the revision surgery on (b)(6) 2018 was for the same side as the revision surgery on (b)(6) 2021 (captured in (b)(4) ).
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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 manufacturing record evaluation was performed for the finished device ccd-01, and no non-conformances / manufacturing irregularities related to the malfunction were identified.18 parts were manufactured per specification.1 part was rejected at op 143 due to a damaged sphere of the bore.

• Brand Name: TOTAL HIP BALL 28MM +8
• Common Device Name: LARGE TAPER 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11841651
• Report Number: 1818910-2021-10545
• Device Sequence Number: 2911033
• Product Code: JDI
• UDI-Device Identifier: 10603295001355
• UDI-Public: 10603295001355
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K860701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1994
• Device Explanted Year: 2018
• 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,Followup
• Report Date (Section B): 05/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1018-14-000
• Device Catalogue Number: 101814000
• Device Lot Number: CCD-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 05/17/2022
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/18/2021; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ENDURON 10D 56 OR (B)(6).; TOTAL HIP BALL 28MM +8; ENDURON 10D 56 OR 68ODX28ID; TOTAL HIP BALL 28MM +8
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female