MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
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
A patient who underwent revision knee surgery before 6 years with the prosthesis mbt tibia and srom noils femur, the insert's rod that set into tibia pocket was broken and lead to dislocation of the knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned devices confirmed the reported event.No product problem has been identified.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS XSM 16MM
• 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: 10489205
• Report Number: 1818910-2020-19414
• Device Sequence Number: 2816053
• Product Code: KRO
• UDI-Device Identifier: 10603295079415
• UDI-Public: 10603295079415
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1987-27-116
• Device Catalogue Number: 198727116
• Device Lot Number: BFA04LG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 11/05/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/22/2020; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS UNIV TIB HIN INS XSM 16MM; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL TRAY; LPS UNIV TIB HIN INS XSM 16 MM; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention