MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-36-152

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 05/11/2020

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

It was reported that the patient had a failed pinnacle liner.The cup was poorly positioned and the superior aspect of the poly broke.The head then articulated with the shell and wore much of the titanium on the shell away.We removed the head, liner and shell and replaced with new implants.Doi: 6 years ago.Dor: (b)(6) 2020.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The provided x-rays and photo images confirmed the reported allegations.The root cause is attributed to inadvertent use error.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.  the poly and cup both have pieces that have fractured and/or worn away.The x-rays confirm that the cup was poorly positioned.The root cause is due to poor placement of the cup.The poor positioning would have contributed to edge loading of the liner/cup construct leading to the poly fracture and subsequent disassociation.

• Brand Name: ALTRX +4 10D 36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10088535
• MDR Text Key: 192037722
• Report Number: 1818910-2020-12582
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016403
• UDI-Public: 10603295016403
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: 1221-36-152
• Device Catalogue Number: 122136152
• Device Lot Number: 479031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 36IDX52OD; ARTICULEZE M HEAD 36MM +12; PINNACLE 300 ACET CUP 52MM; ALTRX +4 10D 36IDX52OD; ARTICULEZE M HEAD 36MM +12; PINNACLE 300 ACET CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR