MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 53MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Model Number 1363-53-000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 07/22/2020

Event Type  Injury  

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 Description

It was reported that patient came to er dislocated.Surgeon explanted current 53 unipolar head ball and +5 tapered sleeve and began trialing with + 5 28 mm and 53 bipolar head ball without luck of stability.He then trialed with +8.5 28mm head ball and still was dissatisfied with stability.He decided to explant summit stem (8std) and implant 8 hi summit stem with + 5 28mm head ball with a dual mobility competitor mdm cup.Surgeon stated he was displeased with depuy¿s ability to provide a dual mobility pinnacle implant.Original implant date unknown.Doi: unknown, dor: (b)(6) 2020, affected side: left hip.

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.

• Brand Name: MODULAR CATHCART BALL 53MM OD
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10362425
• MDR Text Key: 201569697
• Report Number: 1818910-2020-17461
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032854
• UDI-Public: 10603295032854
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1363-53-000
• Device Catalogue Number: 136353000
• Device Lot Number: J0523K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUMMIT POR TAPER SZ8 STD OFF; TAPERED SPACER ARTICUL/EZE +5; SUMMIT POR TAPER SZ8 STD OFF; TAPERED SPACER ARTICUL/EZE +5
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR