MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PRO CONF PL TB ISRT RT S4 12; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number 71508142

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

Patient Problems Pain (1994); Injury (2348)

Event Date 08/01/2018

Event Type  Injury  

Event Description

It was reported that patient underwent primary right total knee replacement by dr (b)(6), (b)(6) 2005.Now presents to surgeon complaining of anterior knee pain.Revision surgery in (b)(6) 2018 involving insert exchange and patella resurfacing (patella not resurfaced at time of primary surgery).

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, all documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The reported anterior knee pain which required resurfacing/revision is not an uncommon occurrence.Given the length of time in-situ (13 yrs), intra-op finding of ¿no problem was found on this device¿, and the patient¿s comorbidities, the root cause of the knee pain is likely multifactorial.The patient impact beyond the reported symptoms, r knee revision/patellar resurfacing tka, and an expected brief post-operative rehabilitation period cannot be determined.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: PRO CONF PL TB ISRT RT S4 12
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, 06340 ; SZ 06340
• MDR Report Key: 7827931
• MDR Text Key: 118610305
• Report Number: 9613369-2018-00055
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• PMA/PMN Number: K946236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Catalogue Number: 71508142
• Device Lot Number: 03KM07667
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 137