MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE REV FEM TRL L LG; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number	2294-29-060
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
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
Surgeon was unable to connect the sample sleeve to the sample femur with the use of screw: 217861100.Allegation against the screw 217861100.Patient: male, (b)(6).Surgery delay: 20min.No adverse patient harm.Surgery performed: mbt revision and lcs vvc by lying spacer.Surgery successfully completed.
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 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.Additional narrative:  added device identification (lot#).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.Additional narrative:  added device identification (lot), concomitant medical products and device manufacture date.Product complaint # (b)(4).Investigation summary: examination of the returned devices confirmed the reported event.The root cause is attributed to mis-use.The device was manufactured on manufactured on (b)(6) 2008.Depuy considers the investigation closed.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 report, a follow-up report will be filed as appropriate.

• Brand Name: LCS COMPLETE REV FEM TRL L LG
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10052547
• Report Number: 1818910-2020-12038
• Device Sequence Number: 19562417
• Product Code: LXH
• UDI-Device Identifier: 10603295113133
• UDI-Public: 10603295113133
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2294-29-060
• Device Catalogue Number: 229429060
• Device Lot Number: AF0208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 06/11/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/11/2020; 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR