MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-456

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

Patient Problems Adhesion(s) (1695); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pcf and medical records received.After review of medical records, patient was revised to address failed left total hip replacement, aseptic loosening of left total hip replacement, and failed metal-on-metal total hip arthroplasty.Patient was with a painful left total hip, was found to have aseptic loosening of her left femoral stem, and was also found to have a metal-on-metal total hip arthroplasty.Operative notes stated that the short external rotators were identified and tagged for later repair.The femoral stem was grossly loose and was able to move it by hand.The s-rom ztt proximal sleeve and stem were well connected.The hoop extractor was used and following removal of lateral bone with a high-speed bur, the stem was removed without any bone loss.It was grossly loose.Reverse curettes were used to clean the pseudomembrane out the femoral canal.Scar and pseudocapsule was debulked.The leg lengths with disarticulation were recreated.The patient was short prior to surgery from the loose subsided stem.Doi: (b)(6) 2011 - dor: (b)(6) 2019 (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: PINNACLE MTL INS NEUT40IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10058893
• MDR Text Key: 191040363
• Report Number: 1818910-2020-12131
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 1218-87-456
• Device Catalogue Number: 121887456
• Device Lot Number: 3007454
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR