MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS MED 18MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-318

Device Problems Device Damaged Prior to Use (2284); Separation Problem (4043)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 11/27/2018

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 a brand new medium srom 18mm poly was opened and the poly was disassociated from the medal hinge.Poly was in two pieces as was unusable.A surgical delay of 20 minutes was noted.Doe: (b)(6) 2018.

Manufacturer Narrative

(b)(4).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 will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: the received device was forwarded to raynham quality engineer for evaluation.Review of the received device revealed the device was disassembled, however, noted damage consistent with suspected use of excessive force was identified.The need for corrective action was not established.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.H10 additional narrative: corrected: h6 (patient,device).No code available (3191) is used to capture surgery prolonged.

• Brand Name: LPS UNIV TIB HIN INS MED 18MM
• 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: 8189157
• MDR Text Key: 131149962
• Report Number: 1818910-2018-78972
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079606
• UDI-Public: 10603295079606
• 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,Followup,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1987-27-318
• Device Catalogue Number: 198727318
• Device Lot Number: BFAOVYL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/04/2019; 06/12/2019; 09/23/2020
• Supplement Dates FDA Received: 01/07/2019; 07/11/2019; 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR