MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 10MM LMRL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-53-310

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 01/06/2020

Event Type  malfunction  

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 surgeon was performing a unicompartmental knee replacement on the left medial compartment on the patient.Normal protocol was taken as far as instruments and implants at the hospital prior to the case.First issue was with the "anterior chisel" through the anterior chamfer of the size 2 cutting block.The chisel (202485000 lot pg0608) split in half inside the cutting block.The block was removed from the distal femur, the broken chisel was then removed from the cutting block.The cutting block was placed back on the distal femur and the lug drill was allowed to pass through the anterior chamfer.This problem did extend the time of the operation.The rest of the operation went smoothly until insertion of the final poly implant.The surgeon has a very detailed and thorough debridement of the implants before he places his final insert component on all of his total and unicompartment knees.There was no cement on the tray, no soft tissue posterior and there was no soft tissue covering the tibial component to prevent insertion of the poly in to the tibial component.The desired poly thickness was opened and matched the implanted lm size 3 tibial component.The initial thickness (9mm) would not seat into the tibial tray when being impacted.The implant was removed and another examination around the tibial component and posterior aspect of the knee was performed.After a few more attempts at inserting the final poly, the underside of the poly was not compatible with the tray.We then opened a size 10mm poly for the tibial component.The same issue described above occurred.A size 11mm was then opened and incurred the same problems above.Finally, we opened a size 8mm insert for the tibial tray and it sat down right away.There was no change in irrigation or care taken to access the tibial component.This problem was very frustrating and increased operative time for the surgeon, staff and ultimately the patient.There was a surgery delay of 60 mins.Doe: (b)(6) 2020, left knee.

Manufacturer Narrative

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.Product complaint # : (b)(4).Investigation summary : the received device was forwarded to commercialized product development at depuy warsaw for evaluation.Examination of the returned devices revealed no product contribution to the reported event and the investigation did not establish a need for corrective action.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.

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.

• Brand Name: SIGMA HP UNI INS SZ3 10MM LMRL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9607958
• MDR Text Key: 189237175
• Report Number: 1818910-2020-02302
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002567
• UDI-Public: 10603295002567
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-53-310
• Device Catalogue Number: 102453310
• Device Lot Number: J4295Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR