MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 40IDX70OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-40-170

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/04/2020

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 the patient had their hip operated on at (b)(6) by dr (b)(6) on (b)(6) 2019.This was also a revision case, but i am not sure of when the original procedure date.It was not in the operative notes.Revision was being done by dr (b)(6).Due to patient instability.Dr (b)(6) believed the acetabular component was not positioned properly and needed to be adjusted.All of the implants were removed from the acetabular side of the patient, and replaced with zimmer components.Dr (b)(6) felt that the femoral stem was well fixed and opted to leave it.Once the zimmer cup was inserted, a trial reduction was performed with our 40mm head trial.A 40mm +12 was found to be satisfactory and implanted.Closing process began.Doi: (b)(6) 2019; dor: (b)(6) 2020; affected side: right 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: ALTRX +4 10D 40IDX70OD
• 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: 10159584
• MDR Text Key: 195375275
• Report Number: 1818910-2020-13915
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295393498
• UDI-Public: 10603295393498
• Combination Product (y/n): N
• PMA/PMN Number: K132959
• 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: 06/04/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1221-40-170
• Device Catalogue Number: 122140170
• Device Lot Number: H62196
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+5; ALTRX +4 10D 40IDX70OD; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN CAN BONE SCREW 6.5MMX50MM; PINN CAN BONE SCREW 6.5MMX50MM; PINN CAN BONE SCREW 6.5MMX50MM; PINN REVISION W/GRIPTION 74MM
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR