MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG CRVD+ INS TRL 1.5 12.5MM; KNEE INSTRUMENT : TIBIAL TRIALS

Catalog Number	972322
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
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
Sigma knee replacement: (b)(6) 2019.Curved plus liners appear to have delaminated after being washed.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the device was reviewed by depuy engineering (b)(6) in a-3270666 which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.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.*** the device was reviewed by depuy engineering (b)(6) in a-3270666 which states: i have assessed this instrument complaint.As is shown by the attached photographs all the trial are stained, scratched and worn.I am unable to ascertain the approx.Year of manufacture from the lot i/d¿s bfi0e6g-bfi0fp0-bfi0fp1-bfi0fp5 & bfi0dx6.My assessment is that this complaint is due to wear and tear.Review of the photo confirmed the devices are stained, scratched and worn.It should be noted the device of lot bfi0e6g was manufactured in mar 2012, bfi0fp0 was manufactured in mar 2012, bfi0fp1 was manufactured in march 2012, bfi0fp5 was manufactured in march 2012, and lot bfi0dx6 jan 2012.Root cause attributed to the device being worn from normal use and servicing.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot = > null.Device history batch = > null.Device history review = > null.

• Brand Name: SIG CRVD+ INS TRL 1.5 12.5MM
• Common Device Name: KNEE INSTRUMENT : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9323477
• Report Number: 1818910-2019-116245
• Device Sequence Number: 2578708
• Product Code: LXH
• UDI-Device Identifier: 10603295250944
• UDI-Public: 10603295250944
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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 Catalogue Number: 972322
• Device Lot Number: BFI0FP1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1