MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC* MOD TIB TRAY NP, SZ 1.5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6027
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	09/08/2020
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
The primary surgery was performed via tka on (b)(6) 2011.It was reported that the revision surgery was performed on (b)(6) 2020.The surgeon found that the screw of the explanted femoral stem¿s part loosened and very wore.No further information is available.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the received device was forwarded to commercialized product development for evaluation.Review of the received device revealed the device was damaged.The investigation found no evidence of product malfunction or product error and 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b5 and d10 corrected: h3.
Event or Problem Description
Additional information received indicated that the reason for surgery was the sinking of the tibial side and then occurring the fracture.Bone fracture was confirmed.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10705313
• Report Number: 1818910-2020-22840
• Device Sequence Number: 16900496
• Product Code: JWH
• UDI-Device Identifier: 10603295216827
• UDI-Public: 10603295216827
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• 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): 09/07/2020

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: 86-6027
• Device Catalogue Number: 866027
• Device Lot Number: 3233369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/08/2020; 02/03/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/19/2020; 02/05/2021
• 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: PFC SIGMA STAB INS S1.5 15MM.; PFC*SIGMA C/S NPOR FE RT SZ1.5.; PFC*SIGMA DIS AUG 8MM/1.5,RGHT.; PFC*SIGMA DIS AUG 8MM/1.5,RGHT.; PFC*SIGMA POST AUG 4MM SZ1.5.; PFC*SIGMA POST AUG 4MM SZ1.5.; PFCSIG +/-2FEMOFFSET STMBLT.; PFCSIGM FEMFLUTROD12X125MM7DEG.; SIGTIBCEMSTM 13X30 1.5/2/2.5/3.
• Outcome Attributed to Adverse Event: Required Intervention