MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL SLEEVE

Catalog Number UNK KNEE TIBIAL SLEEVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Myocardial Infarction (1969); Impaired Healing (2378); No Code Available (3191)

Event Date 01/01/2015

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

An article/literature was received entitled "metaphyseal sleeves for revision total knee arthroplasty: good short-term outcomes¿ literature article "metaphyseal sleeves for revision total knee arthroplasty: good short-term outcomes" by kate e.Bugler et al.Published by the journal of arthroplasty was reviewed.The article purpose: to assess the short term outcomes of the use of metaphyseal sleeves in revision tka.The article reports: this was a study based on a prospective database was compiled of 109 patients undergoing revision tka using a metaphyseal sleeve from depuy.Of the 45 patients remaining after exclusion criteria was applied, full follow up of at least two years was obtained in 35 revision knee arthroplasties.Good patient reported outcomes were found in all measures used.Knee society scores were good or excellent in 83% of patients.There was one intraoperative complications: tibial fracture.There were two early post operative complications: myocardial infarction and wound dehiscence.There were two late post operative complications: joint instability and a femoral fracture.Cement usage was not mentioned.Patella resurfacing was also not conducted in these patients.Stems were also used in most cases and will thus be coded for.Depuy products involved: pfc sigma.Complications: myocardial infarction (1), intra-op tibial fracture (1), wound dehiscence (1), joint instability (1), post-op femoral fracture (1), wound healing delayed (1), surgical intervention (4).

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 KNEE TIBIAL SLEEVE
• Type of Device: KNEE TIBIAL SLEEVE
• 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
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9559533
• MDR Text Key: 185356258
• Report Number: 1818910-2020-00935
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL SLEEVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• 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