MAUDE Adverse Event Report: DEPUY RAYHNAM ¿ 1219655 SIGMA HP UNI INS SZ3 8MM LM/RL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102453308

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 04/30/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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

Surgeon had prepared the femur and tibia for a size 3 partial knee femur and tibia.He felt that it was actually a size 3.5, and didn't cut for a size 4 femur as he thought the ml dimension was too big, therefore he prepared for a size 3.Upon cementing in the tibia and femur, he then found it very difficult to insert the tibial insert into the tibial tray.This went on for some time and whilst trying to insert the insert, the tibial tray was lifting.As he did not have access to another implant of this size, he was forced to remove the tibial tray and recut the tibia to accommodate a size 4.The femur cemented well and was therefore left as a size 3.Surgeon has concern over insert and perhaps it was uneven.

Manufacturer Narrative

This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

While the insert was noted to be deformed and damaged, the damage and deformation is consistent with unsuccessful attempts to mate the tibial insert and tray, and it cannot be confirmed that any of the noted deformation was present prior to these attempts.The root cause, therefore, cannot be definitively determined with the information provided.A complaint database search finds no additional reports against the provided product and lot combination.No evidence was found indicating product error was a contributing factor to the reported assembly problem and the need for corrective action is not indicated.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.

• Brand Name: SIGMA HP UNI INS SZ3 8MM LM/RL
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYHNAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY RAYHNAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5636836
• MDR Text Key: 44608026
• Report Number: 1818910-2016-18735
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 102453308
• Device Lot Number: 749074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR