FDA Adverse Event Injury Summary report: N

PFC SIGMARP STB TB IN 2 12.5

MDR report key: 7150548 · Received December 28, 2017

Report

Report Number: 1818910-2017-52580
Event Type: Injury
Date Received: December 28, 2017
Date of Event: November 30, 2017
Report Date: November 30, 2017
Manufacturer: DEPUY IRELAND 9616671
Product Code: NJL
UDI-DI: 10603295241119
PMA / PMN Number: P830055
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (1894518). DEVICE HISTORY REVIEW: PRODUCT CODE 962112 WORK ORDER (B)(4) WAS MANUFACTURED ON 29 APR 2005. 19 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

DER STATES THE PATIENT FELL POST OP, PS RP INSERT SHEERED OFF AND THE RESULT WAS LATERAL LIGAMENT INSTABILITY. DEPUY CEMENT WAS ALSO USED. DOI: (B)(6) 2007; DOR: (B)(6) 2017; RIGHT KNEE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
931319	PFC SIGMARP STB TB IN 2 12.5	SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT	NJL	DEPUY IRELAND 9616671		1894518	10603295241119

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Required Intervention