MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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, "treatment of crowe iv developmental dysplasia of the hip with cementless total hip arthroplasty and shortening subtrochanteric osteotomy" written by tang liu, sis wang, guoliang huang and wanchun wang published by journal of international medical research doi 10.117/0300060519853383 accepted by publisher 7 may 2019 was reviewed.The article's purpose was to report on finding of results from total hip arthroplasties performed for patients with crowe iv ddh.Data was compiled from 23 hips of 21 patients (19 women 2 men with ages 37-59 years old).Only cementless depuy products were utilized.The article provides patient identifiers for all 21 patients int table 1 and narrative description provides adequate detail to identify which adverse events is associated with each appropriate patient with exception of generalized adverse events.The article also provides radiographic images within the article (figure 2 and 3) for visual purposes.Depuy product: srom hip system with metal-on-poly bearing surfaces.Generalized adverse events: intraoperative non-displaced fractures during femoral stem implantation (left untreated).Sciatic nerve palsy (fully self recovered within 6 months).Patient specific adverse events: patient no 2 left tha (b)(6) female received revision for loose cup 132 months post implantation.Patient no 3 right tha (b)(6) female received revision for loose stem 127 months post implantation.Patient no 5 right tha (b)(6) female received revision for loose stem 121 months post implantation.Patient no 7 left tha (b)(6) female received revision for loose stem 105 months post implantation.Also noted a mispositioned cup of 36.1 degrees inclination and 3.7 degrees anteversion.Patient no 8 right tha (b)(6) female received revision for loose cup 97 months post implantation.Patient no 10 left tha (b)(6) female with noted mispositioned cup of 55.9 degrees inclination and 16.5 degrees anteversion.Patient no 11 right tha (b)(6) female with noted mispositioned cup of 43.6 degrees inclination and 2.3 degrees anteversion.Patient no 14 right tha (b)(6) female with noted mispoisitioned cup of 37.7 degrees inclination and 2.1 degrees anteversion.

Manufacturer Narrative

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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 ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9607536
• MDR Text Key: 189242391
• Report Number: 1818910-2020-02288
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1