MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ4 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Catalog Number 102452400

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/12/2019

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.

Event Description

Revision knee: (b)(6) hospital (b)(6) 2019.Patient underwent primary uni condylar knee replacement on (b)(6) 2019 ((b)(6) hospital) where a sigma partial was utilized.Patient initially did well until 2 weeks post index surgery.Patient has been experiencing tibial pain on weight bearing.Imaging appeared to indicate possible tibial loosening as well as medial overhang.On opening the knee, the insert was removed and the tibial component tested for fixation.The tibial component cam loose with all the cement indicating a failure at the cement bone interface (all cement came out with the component).The tibial plateau was cleaned up, the vertical cut extended laterally to reduce overhang and a new tibial component cemented in situ.A 11mm insert was implanted.Male patient initials (b)(6).Supporting documents: x ray images.

Event Description

The tibial tray had a slight medial overhang at time of index surgery.Ie the tray that was implanted was a little larger ml than the bone bed and therefore had a 1-2mm overhang medially.The affected side is the right knee.

Manufacturer Narrative

Product complaint #: (b)(4).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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.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: SIGMA HP UNI TIB TRAY SZ4 RMLL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8951278
• MDR Text Key: 156159593
• Report Number: 1818910-2019-102691
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002406
• UDI-Public: 10603295002406
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102452400
• Device Lot Number: HW0756
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI INS SZ4 10MM RMLL.; SIGMA HP UNI INS SZ4 10MM RMLL
• Patient Age: 65 YR