MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 21MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-021

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

It was reported that the patient had a chronic dislocation, patient opted for arthrodesis.No surgical delay.Doi: (b)(6) 2019 (tibial tray and tibial sleeve), doi: (b)(6) 2020 (tibial insert, hinge pin and segmental component), doi: (b)(6) 2020 (poly swap and hinge pin), doe: (b)(6) 2020, right knee.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS UNIV TIB HIN INS XXSM 21MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11164048
• MDR Text Key: 226643221
• Report Number: 1818910-2021-00971
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079378
• UDI-Public: 10603295079378
• Combination Product (y/n): N
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/31/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1987-27-021
• Device Catalogue Number: 198727021
• Device Lot Number: J8230T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS DISTAL FEM COMP XXSM RT.; LPS XX-SM HINGE PIN.; MBT REV TIB TRAY SIZE 3 25MM.; MBT TRAY SLEEVE POR M/L 61MM.; UNIVERSAL STEM 115X14MM FLUTED.; LPS DISTAL FEM COMP XXSM RT; LPS XX-SM HINGE PIN; MBT REV TIB TRAY SIZE 3 25MM; MBT TRAY SLEEVE POR M/L 61MM; UNIVERSAL STEM 115X14MM FLUTED
• Patient Outcome(s): Required Intervention