MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP METAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/15/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Clinical symptoms code: appropriate term/code not available (b)(4) used to capture infections.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article entitled, ¿pinnacle ultamet metal-on-metal total hip arthroplasty survivorship: average 10-year follow-up¿, published by arthroplasty today, was reviewed 12/28/2020.The purpose of this study was to do a retrospective review of mom tha completed by a single surgeon with a single implant between 2003 and 2008 was conducted.Patient demographics, implant data, radiographs, and revision details were collected at follow-up.Incidence rates for revision and osteolysis were calculated in regard to the femoral head size, stem offset, neck length, and cup abduction angles.Mom implant systems with longer necks and smaller cup abduction angles may lead to increased need for revision.Results from this study suggest a need for closer long-term follow-up of mom tha systems.The components used were depuy pinnacle ultamet acetabular cups, metal on metal articulation with the s-rom stem/sleeve.692 tha were identified with 544 patient¿s returning for a median follow-up of 10.3 years.The low overall rate of revision for this mom implant is reassuring for surgeons monitoring this patient population, particularly in the face of a potential difficult revision surgery, and serious postoperative complications.Lower cup abduction angles and longer neck lengths in mom implants may predict the need for revision surgery.It is important for surgeons to take into account the implant specifications when making a diagnosis of altr and deciding whether or not to proceed with revision.Mom implants continue to be a challenge, but the data presented here, combined with patient evaluation and radiologic and laboratory studies, can help guide the treatment of this population, leading to prudent decision-making regarding if and when these patients should be revised.There were 37 revision noted with in the 10 year follow-up.Reasons for revisions included: osteolysis, pseudotumor, altr, metal wear due to cup/neck impingement mechanically assisted crevice corrosion, component impingement, failed hardware, instability, and infection.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the x-ray images do appear to depict a depuy metal on metal construct with depuy modular femoral stems in bi-lateral hip replacement.Nothing is noted that is indicative of a product problem.A root cause for the multiple allegations mentioned within the journal article cannot be determined.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: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11132760
• MDR Text Key: 233065073
• Report Number: 1818910-2021-00624
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP METAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention