MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE PATELLA

Catalog Number UNK KNEE PATELLA

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

Patient Problems Syncope (1610); Adhesion(s) (1695); Arrhythmia (1721); Stroke/CVA (1770); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Impaired Healing (2378); 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

The literature article entitled ¿computer navigated versus conventional total knee arthroplasty¿ written by japp j.Tolk, md, et al, published in the journal of knee surgery on 3 may 2012, doi: http://dx.Doi.Org/10.1055/s-0031-1299670, was reviewed.The purpose of the study was to compare the accuracy of alignment reconstruction using conventional and computer-assisted placement of tka.The effect of cas on functional outcome was also analyzed.Depuy product used: lcs tka.There were 50 conventional (conv) and 50 computer assisted (cas) tka¿s performed with follow-up.There was patellar resurfacing in (5) cases.Cement manufacturer not noted.There were (8) complications in the conv group and (6) complications in the cas group.Adverse events were as follows: conv group: postoperative delirium, postoperative cerebral infarction, delayed wound healing, superficial wound infection, deep infection, additional surgery to remove drain and revision surgery with adhesiolysis.Cas group: postoperative atrial fibrillation, arthrofibrosis, delayed wound healing, peroneal palsy, vasovagal syncope and patellar resurfacing for anterior knee pain.

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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE PATELLA
• Type of Device: KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9997868
• MDR Text Key: 188975635
• Report Number: 1818910-2020-11298
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE PATELLA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention