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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pulmonary Embolism (1498); Joint Dislocation (2374); No Code Available (3191)

Event Date 09/12/2014

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 entitled, "squeaking in large diameter ceramic-on-ceramic bearings in total hip arthroplasty" written by stephen m.Tai, mbbs, bsc(hons), frcs (tr & orth) , selin munir, mbiomed, beng(hons), william l.Walter, fracs, faortha, phd, simon j.Pearce, mbbs, frcs (tr & orth), william k.Walter, mbbs, fracs, faortha, and bernard a.Zicat, md, fracs, faortha the journal of arthroplasty 30 (2015) 282¿285 accepted by publisher 12 september 2014 was reviewed.The article's purpose: "the aim of the study was to report the short-term clinical and radiological results of the deltamotion cup, together with the incidence of post-operative squeaking." data was compiled from 206 thas (195 patients) with follow up markers at 6 weeks, 6 months and 2 years.Depuy products utilized: deltamotion cup, sleeve (augment), ceramic head.The article provides information that the stem was a non-depuy product.These products were used on all hips.Adverse events: squeaking (no interventions provided), mispositioned cups (relation to other adverse event is not clarified), pulmonary embolism, dislocation (associated with recurrent falls due to alcohol-related cerebellar ataxia treated by revision surgery to reconstruct soft tissue damage - only head was replaced along with longer neck sleeve - as cup and stem were well fixed) femoral peri-prosthetic fracture leading to loose stem(treated by revision surgery - no further details provided), peri-prosthetic peri-acetabular fracture that resulted in loose cup (treated by revision - no further details provided).

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 HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9307591
• MDR Text Key: 182054609
• Report Number: 1818910-2019-111717
• Device Sequence Number: 1
• Product Code: KWA
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention