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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 04/25/2016

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.(b)(4).

Event Description

The literature article "poor performance of enduron polyethylene liner in total hip arthroplasty: a minimum ten-year follow up and ultra-morphological analysis of wear particles" by yufei yan & hao chen, jianmin feng, kaizhe chen, kaidi zhou, weixiang hong, yi wang, zhihong liu, jiong zhang, qingming yang, lei guo and chuan he published by international orthopaedics doi 10.1007/s00264-016-3217-0 on 25 april 2016 was reviewed for mdv reportability.Purpose: "in this study, we hypothesized that different types of nonecross-linked polyethylene liners have different clinical performance, which is related to the wear characteristics of polyethylene including the wear rate and the size of wear particles.We then evaluated the long-term (more than ten years) outcome of patients who underwent thas using two types of none-cross-linked polyethylene liners¿enduron (depuy, warsaw in, usa) and trilogy (zimmer, warsaw in, usa).We also performed morphological analyses of wear particles in tissue samples which were harvested during revision surgery." the depuy duraloc acetabular cup was used in the enduron group (cocr alloy femoral heads and 36 cemented and 43 uncemented femoral stems).Among 116 thas in the enduron group, 34 thas were lost to follow-up at ten years post-operative, two patients died of unrelated causes, and one patient was re-operated upon because of a periprosthetic fracture(anatomic location unspecified), which left us 79 thas for analysis and 12 of them were telephone interviews.Three thas in the enduron group and two thas in the trilogy group had dislocation within one year after operation.No deep venous thrombosis happened in both groups.A total of ten thas in the enduron group were revised, eight of which were due to aseptic loosening and the other two were due to infection.In our study, revision of any component was evaluated.For the aseptic loosening cases, three of them were due to acetabular loosening and five of them were due to acetabular and femoral components loosening.Four loosened stems in aseptic loosening cases were cemented, and the other four were non-cemented.These revisions occurred between 6.0 and 11.4 years after the index surgery.Enduron liners had pelvic and/or femoral osteolytic lesions.Tissues from the synovial capsule and bone implant interface were obtained from three patients undergoing revision arthroplasty in the enduron group.Polyethylene particles are visible under polarized light micrograph (birefringent), but not under normal light micrograph." impacted products: enduron liner, unknown femoral head.Unknown femoral stem, duroloc cup.Adverse events: surgical revision, pain, cup loosening, stem loosening (both cemented and uncemented), dislocation, osteolysis, infection, foreign body reaction.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9006734
• MDR Text Key: 162011408
• Report Number: 1818910-2019-103713
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• 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: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention