MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 47X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-47-000

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

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 09/28/2020

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 this patient had her left hip replaced 20 + years ago, the surgeon, hospital where she had her surgery is unknown.The xrays revealed the patient most likely had a hps ii stem with a bipolar shell.The patient is a regular patient of (b)(6) now and spike with him about her painful left hip.Dr.(b)(6) determined the source of the pain would be due to the loss of cartilage and bone in the acetabulum due to 20+ years of a metal shell articulation on the cartilage and bone.It was decided he would revise the construct to a total hip from a hemi.Dr.(b)(6) removed the femoral head and bipolar shell while leaving the hps ii stem in situ.He reamed the acetabulum and prepared for a pinnacle cup.A cup implant and liner was implanted and a new femoral hip ball was implanted on the stem.The lot #¿s of the femoral stem and bipolar shell were unable to be retrieved.Doi: 20 + years ago, dor: (b)(6) 2020, affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.A singular x-ray image has been provided and reviewed.Nothing indicative of a product problem is identified.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.

• Brand Name: SELF CENT HIP 47X28 BRN
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10677568
• MDR Text Key: 211295750
• Report Number: 1818910-2020-22277
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003373
• UDI-Public: 10603295003373
• Combination Product (y/n): N
• PMA/PMN Number: K812672
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1035-47-000
• Device Catalogue Number: 103547000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (HPS II STEM); ARTICUL/EZE BALL 28 +1.5 GR; (HPS II STEM); ARTICUL/EZE BALL 28 +1.5 GR
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 77