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
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Separation Problem (4043)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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
• Common Device Name: 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
• Report Number: 1818910-2018-78972
• Device Sequence Number: 13928422
• Product Code: KRO
• UDI-Device Identifier: 10603295079606
• UDI-Public: 10603295079606
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/04/2019; 06/12/2019; 09/23/2020
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/07/2019; 07/11/2019; 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR