MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL SLEEVE; KNEE: SLEEVE

Catalog Number UNK KNEE TIBIAL SLEEVE

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Health effect - clinical code: (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 this is part of a serial i&d with a poly exchange from the case on (b)(6) 2012 with the following comments listed there: patient has been being treated for chronic infection in gj.Came for further treatment.I&d with poly exchange scheduled.Tibia was loose upon intra-operative evaluation ( sigma mbt w a sleeve and press fit stem - not product numbers or lot numbers).The tibia disengaged from the sleeve but the sleeve did not move.It was decided to clean up the exposed tibia instu and reinsert it with cement on the undersurface.This was due to the poor health and age of the patient.Serial i&ds may be performed.Unknown date or location of insertion of the components.Doi: (b)(6) 2021.Dor: (b)(6) 2021.Right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN KNEE TIBIAL SLEEVE
• Type of Device: KNEE: SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12342454
• MDR Text Key: 267270301
• Report Number: 1818910-2021-18178
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• 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: 07/29/2021

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 Catalogue Number: UNK KNEE TIBIAL SLEEVE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); TC3 RP TIBIAL INSERT S4,17.5; UNK KNEE TIBIAL TRAY; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); TC3 RP TIBIAL INSERT S4,17.5
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 89