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 Unspecified Infection (1930); Joint Dislocation (2374); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Literature article entitled ¿comparison of complications between different surgical approach after total hip arthroplasty: a single high-volume center, retrospective case-control study" written by shi xiaojun, zhao haiyan, releken yeersheng, kang pengde, pei fuxing.Publishing company and date of publication not provided.The article's purpose was to compare complications after tha through direct anterior approach versus posterior lateral approach.Patient data: a retrospective analysis was performed in a total of 1546 consecutive patients (1780 hips) who underwent primary tha by one experienced surgeon from june 2012 to june 2017.Depuy products: cementless prosthesis; pinnacle cup and liner was used on the acetabular side, short stem was trilock prosthesis, and non-short stem included s-rom, corail, and solution stem (all products utilized in the study were depuy, however, the article does not detail which aes relate to which product line of depuy.Therefore, all aes will be captured with unk stem).Adverse events: (25) intra-op periprosthetic femoral fracture ¿ treated with intra-op fixation.(7) postoperative hip dislocation - treated with closed reduction.(33) wound fat liquefaction ¿ conservative treatment.(7) superficial wound infection ¿ conservative treatment.(1) deep infection ¿ revision.(21) malpositioning of stem ¿ conservative treatment.(17) malpositioning of cup ¿ conservative treatment.(82) leg length discrepancy ¿ conservative treatment.

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.

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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14743341
• MDR Text Key: 295028158
• Report Number: 1818910-2022-11258
• 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: 06/20/2022

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 FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/09/2022
• 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