MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 SROM NRH TIB PLAT ASSY MED21MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number	621623
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/18/2018
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 because of fracture of peg of rotating hinge tibial plateau.
Additional Manufacturer Narrative
(b)(4).No product was returned.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.No anomalies identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: no product was returned.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: no anomalies identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM NRH TIB PLAT ASSY MED21MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8055832
• Report Number: 1818910-2018-75143
• Device Sequence Number: 1436853
• Product Code: KRO
• UDI-Device Identifier: 10603295179030
• UDI-Public: 10603295179030
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 621623
• Device Lot Number: 3161623A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 12/05/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/06/2018; 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention