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); Migration (4003)

Patient Problems Pain (1994); Pocket Erosion (2013); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/28/2005

Event Type  Injury  

Manufacturer Narrative

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.(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 abstract entitled, ¿determination of crystallinity and crystal structure of hylamer polyethylene after in vivo wear¿ by m.Visentin, et al, published by journal of biomaterials applications (2006), vol.21, pp.131-145, was reviewed.The purpose of this article was to evaluate the wear of hylamer polyethylene liners explanted during cup and liner revision.Implanted depuy products: duraloc cup and hylamer polyethylene liner.The femoral components used were unknown.Results: the authors report on the polyethylene wear for 9 patients.All cups and liners were revised due to pain, acetabular bone erosion, cup loosening, and cup migration secondary to excessive wear of the polyethylene liner.This complaint captures 9 individual cases labeled case 1 through case 9.The parent (b)(4) includes case 1.Case 2 through case 9 are linked to this pc." (b)(6) y/o male duraloc cup and hylamer liner revised due to pain, aseptic loosening, cup migration, and acetabular bone erosion secondary to excessive polyethylene liner wear.

Manufacturer Narrative

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, 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9371682
• MDR Text Key: 185011492
• Report Number: 1818910-2019-117040
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR