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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 09/04/2017

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, ""cementless total hip arthroplasty in young patients under the age of 30: a minimum 10 year follow-up"" written by kyoung ho moon and eun ho shin published by hip international accepted by publisher 4 september 2017 was reviewed.The article's purpose was to review the clinical and radiographic outcomes of young patients who received a tha under the age of 30 in which the patients had been followed up for more than 10 years.The data was compiled from 44 patients (51 hips) with an mean age of 25.71 years and mean follow-up period of 13.7 years.All femoral components were depuy products: aml (42), solution (3), and srom (6).Acetabular components were all duraloc shells with the exception of 1 non-depuy shell.Femoral heads were ceramic (48) and metal (3) and liners were enduron poly (27) and ceramic (24).It is noted that table 5 page 5 provides 8 cases of revisions due to loosening of cup and/or stem which is captured individually (femoral components specified along with identiy of loose components) in linked complaints illustrating higher rate of revision among smaller femoral head components." this complaint captures case 7 with l osteolytic lesion and received revision of both components 133 months post initial implantation for loosening on each.The cup was duraloc and the stem was aml stem, ceramic head and enduron pe liner.The article associates osteolysis and osteolytic lesions due to wear of poly liner.

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.H10 additional narrative: corrected: h6 (closure codes and device codes).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 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: 9255861
• MDR Text Key: 177066157
• Report Number: 1818910-2019-109845
• Device Sequence Number: 1
• Product Code: LPH
• 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: 10/07/2019

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 ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention