MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CNTR HIP 43X22.225 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number	1037-43-000
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
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
The primary surgery was performed on (b)(6) 2003 via bha.Around 2019, the patient had a light pain and felt something wrong with the hip joint.It was confirmed by x-ray that a dissociation had occurred by eccentric wear of the polyethylene liner.The revision surgery was scheduled to be performed by replacing the bipolar cup (p/n: 103743000) and the head (p/n: 152190051) and the liner (p/n: 134521000) on (b)(6) 2020.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SELF CNTR HIP 43X22.225 GRY
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9899213
• Report Number: 1818910-2020-09605
• Device Sequence Number: 2764961
• Product Code: KWY
• UDI-Device Identifier: 10603295003564
• UDI-Public: 10603295003564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 1037-43-000
• Device Catalogue Number: 103743000
• Device Lot Number: XE7CH1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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: 9/10 COCR HEAD 22.225MM -3; AML A PLUS 10.0 MM