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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Use of Device Problem (1670); Osseointegration Problem (3003)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526); Muscle/Tendon Damage (4532); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/03/2019

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, ¿zirconia phase transformation in zirconia-toughened alumina ceramic femoral heads: an implant retrieval analysis¿ by thu m.Nguyen, ms, et al, published by the journal of arthroplasty, volume 34, issue 12, december 2019, pages 3094-3098, was reviewed.The study examined the effects of in vivo and artificially-aged phase changes on the burst strength of zirconia-toughened alumina ceramic femoral heads.Twenty-eight zirconium composite alumina ceramic heads were retrieved during revisions, involving four different manufacturers, three different diameters (3 were 28 mm in diameter, 9 were 32 mm, and 16 were 36 mm).It was also noted that other products also revised, affecting four different manufacturers: regarding depuy, there was 1 marathon xlpe and 1 altrx xlpe and 1 non-xlpe polyethylene liner, and 1 tri-lock stem and 1 srom stem.This suggests that there were possibly five ceramic femoral heads from depuy revised, of the twenty-eight total.The following reasons for revision and the number of associated femoral heads retrieved was provided by the authors: loosening: 8, altr: 3, infection: 3, dislocation: 1, fracture: 4, malpositioning: 1, abductor tear: 1, heterotopic ossification: 1, leg length discrepancy: 1, pain: 1, unknown: 4.No other details were provided, nor was information provided that associated manufacturers with the various reasons for revision.Additionally, authors reported that an unspecified number of retrieved femoral heads had metallic scoring, indicative of impingement of the femoral head with the edge of the titanium acetabular cup.Results: although showing evidence of phase change, the heads achieved a burst load far above the 46 kn food and drug administration acceptance criterion, with 3 having burst strengths exceeding 100kn.The study showed that phase transformation occurs in vivo in ceramic composite femoral heads, but the amount transformed does not increase with the length of time the head are implanted.The effect upon burst strength of the retrieved heads is negligible.Impacted products: 1 unknown trilock stem, 1 unknown s-rom stem, 1 unknown s-rom augment, 1 unknown marathon xlpe liner, 1 unknown altrx liner, 1 unknown polyethylene liner, 5 unknown delta ceramic femoral heads.

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 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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11114513
• MDR Text Key: 233124414
• Report Number: 1818910-2021-00152
• Device Sequence Number: 1
• Product Code: MRA
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention