MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ1 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-12-070

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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 patient had increasing hip & groin pain.Head & liner exchange.After review of medical records, it was indicated that patient presents with progressive weight-bearing pain and some intermittent mechanical symptoms of catching or ratcheting in her right hip.Her evaluation revealed that she did have elevated cobalt and chromium ion levels, and an mri did show a moderate-sized periarticular fluid collection.The patient was then revised for failed right total hip arthroplasty due to metallosis and local adverse tissue reaction as well as early periacetabular osteolysis.Operative notes reported that there was blackish and grayish metallosis staining within the synovial lining diffusely of the hip joint, and there was some wear debris within the capsular structures.There was clear trunnionosis with wear debris at the junction of the femoral head and the trunnion.There was some mild yellowish wear debris on the posterior aspect of the liner, surgeon felt the majority of the metallosis wear debris was from the trunnion.There was evidence for some osteolysis.Doi: (b)(6) 2007; dor: (b)(6) 2019; 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.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT DUOFIX TAP SZ1 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9928393
• MDR Text Key: 186547231
• Report Number: 1818910-2020-10231
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060123
• UDI-Public: 10603295060123
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-12-070
• Device Catalogue Number: 157012070
• Device Lot Number: BY1A81000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 63