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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Hemorrhage/Bleeding (1888); Impaired Healing (2378); Joint Laxity (4526)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.Literature citation: mou p, zeng wn, chen y, zhou z.Synchronous or sequential cementless bilateral total hip arthroplasty for osseous ankylosed hips with ankylosing spondylitis.Bmc musculoskelet disord.2021 mar 24;22(1):302.Doi: 10.1186/s12891-021-04142-7.Pmid: 33761925; pmcid: pmc7988988.Objective/methods/study data: 23 patients (46 hips) were retrospectively analyzed and divided into bilateral tha synchronously (group a) and sequentially (group b).The clinical measurement, radiological assessments, and complications were compared.Independent sample t test was used for data analysis.Only one single brand (depuy) of the cementless cup and stem implants were used for all patients.The friction interfaces used included ceramic-on-ceramic (coc) or ceramic-on-polyethylene (cop), which were decided according to the age, level of activity, and patients¿ financial situation.The article does not identify which depuy products were utilized.Figure 1 depicts a man with bilateral tha with no adverse events noted but no identity of the specific depuy products utilized.Caption reports radiograph at 100 month shows no aseptic loosening or migration.Figure 2 depicts a man with single and then contralateral tha's with no adverse events and no identity of the specific depuy products utilized.Caption reports 97 month follow shows good fixation.Adverse event(s) and provided interventions: qty unknown blood transfusions administered.Qty 2 femoral fracture intraoperatively fixed with several double-loop cerclage wires - patients conducted functional exercise in bed until fracture healed.Qty 1 patient experienced hip dislocation and delay union of wound.Qty 6 heterotopic ossification.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15102344
• MDR Text Key: 296571193
• Report Number: 1818910-2022-13985
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention