MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 48X28 BRN HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-48-000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised due to loosening of the unknown component at the bone to implant interface. Revision of a bipolar hip to a total hip due to peri-prosthetic fracture and recurrent dislocations. Do not know original surgery date. Doi: unknown, dor: (b)(6) 2021, (left hip).

• Brand Name: SELF CENT HIP 48X28 BRN
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12505331
• Report Number: 1818910-2021-20584
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003380
• UDI-Public: 10603295003380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1035-48-000
• Device Catalogue Number: 103548000
• Device Lot Number: JC3914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Treatment(s): ARTICUL/EZE BALL 28 +1.5 GR; SELF CENT HIP 48X28 BRN; SUMMIT BASIC PRESS FIT SZ 7
• Patient Outcome(s): Required Intervention