MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PRO CONF TB ISRT RT S5 12; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71507152
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was admitted to the (b)(6) hospital due to an infected knee.Patient had original surgery of right profix tkr approximately 14 years ago.No previous operative notes available.Knee was opened and thickened haemoserous fluid was noted.Tibial poly was exchanged.Explanted device unable to be retrieved due to infectious reasons.
Additional Manufacturer Narrative
The affected profix conforming articular insert was not returned for evaluation.After repeated requests, sn has been unable to obtain the batch number for this device, thus device history record review cannot be completed at this time.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that without supporting clinical/medical documents a thorough investigation cannot be performed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: PRO CONF TB ISRT RT S5 12
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 7985261
• Report Number: 9613369-2018-00069
• Device Sequence Number: 18874127
• Product Code: JWH
• UDI-Device Identifier: 03596010220073
• UDI-Public: 03596010220073
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71507152
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2018
• Supplement Date Received by Manufacturer: 09/22/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention