MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL HIP BALL 28MM +11; 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 Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	05/03/2006
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
Clinical notification received for revision of right total hip to address hip dislocation date of implantation: (b)(6) 1995, date of revision: (b)(6) 2006, (right hip).Treatment: revision of depuy femoral head and competitor acetabular liner.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: TOTAL HIP BALL 28MM +11
• 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
• MDR Report Key: 10792115
• Report Number: 1818910-2020-24005
• Device Sequence Number: 3267255
• Product Code: JDI
• UDI-Device Identifier: 10603295001355
• UDI-Public: 10603295001355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K860701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2020

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: 101871000
• Device Lot Number: R75CJ1031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/09/2020; 12/03/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 11/17/2020; 12/09/2020
• 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: AML MMA 13.5MM 6.3 IN STEM; COMPETITOR BONE SCREW; COMPETITOR CUP (REFLECTION SHELL); COMPETITOR LINER (REFLECTION LINER); AML MMA 13.5MM 6.3 IN STEM; COMPETITOR BONE SCREW; COMPETITOR CUP (REFLECTION SHELL); COMPETITOR LINER (REFLECTION LINER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 73