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

Event Date 02/07/2011

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, "an analysis of stably fixed femoral components retained during revision total hip arthroplasty" written by hyung joon cho, md, seung beom han, md, phd, jong hoon park, md, phd, and sang won park, md, phd published by the journal of arthroplasty vol.26 no.8 2011 accepted by publisher 7 february 2011 was reviewed.The article's purpose: "to evaluate overall clinical outcomes and the radiographic results of revision hip arthroplasties involving only the acetabular component, with a particular focus on thorough assessment of the condition of the nonretrieved femoral stem." data was compiled from 26 patients (29 cases/hips) of revision tha occurring between january 1998 and december 2004 with average age of 54.3 years and average time from primary operation to revision of 9.2 years and average follow up of 5 years.Most common cause of revision surgery was osteolysis accompanied by failure of the locking mechanism and liner dissociation (also note of aseptic loosening, recurrent dislocation).It is noted in table 2 that 2 duraloc cups were utilized in 2 of primary cases (that were revised) and then 2 in the revision cases along with 2 aml stems.All bearing surfaces were mop and various non depuy products are listed for both primary cases and revision cases.Results post revision: pain, osteolysis in acetabular and femoral locations, cortical hypertrophy and calcar resorption, dislocation treated by closed reduction and bracing, heterotrophic ossification.Adverse events that can be associated with depuy duraloc cup and aml stem: surgical revision (from list of primary tha).The article does not specify which specific failure is associated with depuy products but at least one or more of the following: osteolysis associated with poly wear, failure of locking mechanism and dissociation of liner, aseptic loosening of cup (stems were left intact), recurrent dislocation.Although not stated, it is reasonable to conclude a depuy femoral head was utilized in conjunction with the duraloc cup and aml stem.

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: 9249597
• MDR Text Key: 174621898
• Report Number: 1818910-2019-112784
• 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

• Date FDA Received: 10/29/2019
• 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: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention