MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 01/01/2019

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.

Event Description

The literature article entitled, "mid-term outcome of total hip arthroplasty in patients with progressive pseudorheumatoid dysplasia" written by bin feng, md, ke xiao, md, yi ren, md, zenan xia, md, jin, md, zhihong wu, md, guixing qiu, md, and xisheng weng, md published by journal of clinical rheumatology 2019 was reviewed.The article's purpose was to investigate the clinical and radiological outcome of ppd patients undergoing tha after mid-term follow-up.Data was compiled from 8 cases.All received depuy implants.Figure 4 provides radiographic image of implants with no adverse event in caption description.Depuy products: pinnacle cup, srom stem, corail stem, cup screw, ceramic head, ceramic liner.Adverse event: case 2 had a perforation of posterior cup screw and impinged the sciatic nerve (treated by surgery with removal of screw with patient experiencing full recovery afterwards) one patient (case number unknown) report inguinal pain 1 month post implantation due to "dysplasia of the socket and cup anterior overhang" (treated by observation and non-steroid anti-inflammatory drugs prescribed with pain disappearing at 3 months post op).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached images could not confirm the reported allegations for this complaint.A root cause could not be determined.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10941038
• MDR Text Key: 219362247
• Report Number: 1818910-2020-26068
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention