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 Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

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, ¿porous-coated cementless acetabular cups in revision surgery: a 6- to 1 1-year follow-up study¿ by eduardo garcia-cimbrelo, md, phd, published by the journal of arthroplasty (1999), vol. 14, no. 4, pp. 397-406, was reviewed. The purpose of this article was to review the efficacy of various types of acetabular bone grafting utilized during revision surgery performed between 1986 and 1991. The cups used in the index and revision surgeries were from various manufacturers. The authors utilized an unknown number of screws and unknown bone graft to secure the revision cups. The femoral components used are unknown. The authors used constrained liners assumed to be of the same manufacturer as the cup. There is insufficient information provided to determine the actual number of depuy products associated with the adverse events and radiographic findings noted within the article. Index tha components: 2 acs cups revised due to loosening of the bone to implant interface. Revision components: 14 duraloc cups paired with constrained liners and secured with an unknown number of acetabular screws. Re-revisions and interventions: an unknown number of cups and screws were revised due to cup loosening at the bone to implant interface. 3 duraloc cups were identified as ¿mechanical failures¿ due to pain. Treatment was unspecified. Progressive radiographic findings: unknown number of cups and screws were identified as migrated, loosened at the bone to implant interface. There were radiolucent lines found in one or more delee-charnley zones. 6 hips had radiographically identified broken screws. Fig. 6 on page 404 and fig. 4 on page 402 provides radiographic images of unknown loosened cups and broken screws. ".

• 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 ; 700 orthopaedic dr; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9677618
• MDR Text Key: 189143556
• Report Number: 1818910-2020-04158
• 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,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/06/2020 Patient Sequence Number: 1