MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 42X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number	1035-42-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/14/2021
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 the metal portion of the bipolar became disassociated from the polyethylene of the bipolar.Poly was still attached to the femoral head and metal was loose in the joint.Doi: (b)(6) 2019, dor: (b)(6) 2021, right hip.
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.H10 additional narrative: added: b5 and h6 (impact code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received indicated that the surgery time was extended because the whole surgery (45 minutes) was to retrieve the broken part and implant a new femoral and bipolar head.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: SELF CENT HIP 42X28 RUST
• 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: 11891719
• Report Number: 1818910-2021-11358
• Device Sequence Number: 3633054
• Product Code: KWY
• UDI-Device Identifier: 10603295003328
• UDI-Public: 10603295003328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 05/14/2021

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: 1035-42-000
• Device Catalogue Number: 103542000
• Device Lot Number: J5429X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/31/2021; 06/22/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/10/2021; 06/25/2021
• 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: ARTICUL/EZE BALL 28 +5 BR; ARTICUL/EZE BALL 28 +5 BR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR