MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-112
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Swelling (2091); No Code Available (3191)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Revision of unknown parts of a lps knee system because of inlay failure.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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.Product complaint # (b)(4) investigation summary - update 11-june-2020: the investigation was re-opened upon receipt of the product.Examination of the returned device could not confirm the reported event.The device was manufactured on 12/13/2016.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history "lot number: h20956.Product code: 198727112.Bfarm request, please provide 1) quantity manufactured ¿ (b)(4).2) date of manufacture- (b)(6) 2016.3) any anomalies or deviations identified in dhr- na 4) expiry date - 11/30/2021.5) ifu reference-090200773 rev j." if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS XSM 12MM
• 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: 9908097
• Report Number: 1818910-2020-09815
• Device Sequence Number: 10938029
• Product Code: KRO
• UDI-Device Identifier: 10603295079392
• UDI-Public: 10603295079392
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2020

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 Expiration Date: 11/30/2021
• Device Model Number: 1987-27-112
• Device Catalogue Number: 198727112
• Device Lot Number: H20956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 06/11/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/08/2020; 06/11/2020
• 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 CEMENTED STEM 16X125MM STR; LPS DISTAL FEM COMP XSM RT; MBT REVISION CEM TIB TRAY SZ; MBT TRAY SLEEVE POR M/L 61MM; UNIVERSAL STEM 115X16MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 78