MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-36-154

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/08/2021

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

Original implant date unknown.Dr.Said the patient came in with a dislocated hip.He wanted to perform a head and liner exchange while doing an open reduction.Dr believed a pinnacle dual mobility liner would be the best option for this patient with their dislocation history.When i asked dr about this patient's history of revisions, he wasn't sure of when they took place, and who performed the procedures.When shown the x-rays, it appeared to be our acetabular component, but not our femoral stem.Upon opening the hip, it was confirmed the liner did belong to depuy, but the femoral head was competitor.Once the dm liner was implanted, a trial reduction was performed with zb's 28mm head and our dm liner trial.Once the desired head was found, the parts were opened, assembled, and implanted.The hip was found to be stable, so the closing process began.Doi: unknown, dor: (b)(6) 2021, affected side: left hip.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.It has been reported the depuy acetabular device had been implanted in conjunction with a competitor manufactured femoral device.This is considered off label use.The information received will be retained for potential series investigations if triggered by trend analysis 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 device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: ALTRX +4 10D 36IDX54OD
• 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: 11366158
• MDR Text Key: 233097437
• Report Number: 1818910-2021-03655
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016410
• UDI-Public: 10603295016410
• Combination Product (y/n): N
• PMA/PMN Number: K072963
• 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: 02/08/2021

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
• Device Operator: Health Professional
• Device Model Number: 1221-36-154
• Device Catalogue Number: 122136154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR STEM; ZIMMER BIOMET FEMORAL HEAD; COMPETITOR STEM; ZIMMER BIOMET FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR