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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Renal Failure (2041); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 02/15/2016

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

"literature article entitled, ¿a modern constrained acetabular component for the management of hip instability¿ by dror maor, et al, published by journal of musculoskeletal research (2016), vl.19, no.1, article id 1650002, 7 pages, doi: 10.1142/s0218957716500020, was reviewed.The authors report clinical and radiological findings in 76 patients treated with a constrained liner for those considered at high-risk for dislocation, intraoperative instability or recurrent dislocations.Mean follow up was 12 months.Post operatively there were two cases of recurrent dislocation, one aseptic loosening and nine cases of deep infection.These results support that these liners have been used to treat, or in some cases prevent, instability after total hip replacement.Implanted products: this study reports the clinical and radiological findings in patients treated with the pinnacle constrained liner (depuy) for those considered at high-risk for dislocation, intraoperative instability or recurrent dislocation.The acetabular cup is the uncemented pinnacle cup in 74 patients and 2 cemented pinnacle cups.The median femoral head size was 32-mm.There was a median of two screws used to secure uncemented cups.The make and manufacturer of the femoral stem are unknown.Results: 7 grade 1 and 4 grade 2 heterotopic ossification.1 revision of the liner for osteolysis and dislocation.15 cases of serial radiographically confirmed osteolysis (liner and head)- no revision or intervention.2 cases progressive loosening of cup radiographically identified, treatment unspecified.1 revision for dislocation.1 revision for deep infection and dislocation of spacer from liner during the two-stage revision to treat this deep infection.Manufacturer of the temporary spacer is unknown.6 superficial wound infections treated with antibiotic.1 deep infection and dislocation- converted to girdlestone due to inability to control infection.4 ¿cardiac events¿.Events and treatment are unspecified.4 ¿chest infections¿.2 advanced into renal failure.Treatment and type of chest infections are unspecified.1 asymptomatic aseptic cup loosening not revised due to patient comorbidities making them unable to tolerate surgical intervention.5 additional deep infections: i treated with l & d and liner exchange, 1 treated with i & d only, 3 treated with long-term oral antibiotics.There was a total of 7 reoperations in this study.The stem is unknown.Therefore, the revision of the stem for loosening is not captured in this complaint.Captured in this complaint: pinnacle cup, pinnacle constrained liner, unknown femoral head.There were no reported events associated with the screws used to secure some of the uncemented cups.There were no reported events associated with the two cemented pinnacle cups.The types of the chest infections are unknown, and are captures as "infections" in this complaint.They types of cardiac events are unknown and are therefore not captured within the guidance document but included in the event description.".

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 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.Product complaint #
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>(b)(4).Investigation summary
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> 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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).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).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.

• 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: 9216204
• MDR Text Key: 176338365
• Report Number: 1818910-2019-108704
• Device Sequence Number: 1
• Product Code: KWA
• 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,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention