MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS MED 21MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number	198727321
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374); Not Applicable (3189)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 reported to bfarm: primary knee tep-left side on 2002.After trauma/fracture change in (b)(6) 2007.Tibial change after loosening in (b)(6) 2011.Change of femoral components after fracture in 2014.In mid of (b)(6) 2017 patient reported a sudden pain while treading.Since this mobilisation with help of crutch, analgesia with indometacin.X-ray showed fracture of tibia and dislocation.Revision on (b)(6) 2017.Doi: 2014; dor: (b)(6) 2017; left knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device(s) confirms the reported event.Product problem has not been identified.Depuy considers the investigation closed at this time.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 medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: LPS UNIV TIB HIN INS MED 21MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7411561
• Report Number: 1818910-2018-56988
• Device Sequence Number: 962957
• Product Code: KRO
• UDI-Device Identifier: 10603295079613
• UDI-Public: 10603295079613
• Combination Product (Y/N): N
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 198727321
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/11/2018
• 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
• Patient Age: 68 YR
• Patient Weight: 100