LRG TAP PRI MOD NCK 0DEG 34MM

Report

Report Number: 0002249697-2013-00084
Event Type: Injury
Date Received: January 17, 2013
Date of Event: January 19, 2012
Report Date: January 2, 2013
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: LZO
PMA / PMN Number: K092561
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN ABGII/REJUVENATE NECK. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 1

THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING REVISION DUE TO PAIN INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THE COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. CONCLUSIONS VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED REVISION DUE TO PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

Additional Manufacturer Narrative · 1

THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

Description of Event or Problem · 1

IT WAS REPORTED THAT: PATIENT IS EXPERIENCING PAIN SINCE HAVING SURGERY. PAIN HAS INCREASED STEADILY ALSO SINCE HAVING SURGERY. PATIENT STATES HAVING DIFFICULTY WALKING AND IS UNABLE TO DO ANY HEAVY LIFTING. PATIENT ALSO STATES THAT SHE IS ALWAYS COLD ON THE LEFT SIDE. PATIENT IS SCHEDULED TO HAVE BLOOD TEST ON (B)(6) 2013.

Description of Event or Problem · 1

IT WAS REPORTED: THE PATIENT WAS REVISED ON THE LEFT HIP DUE PAIN. THE CUP REMAINED IMPLANTED. NO FURTHER INFORMATION OR DOCUMENTATION WILL BE PROVIDED DUE TO HOSPITAL POLICY.

Description of Event or Problem · 1

IT WAS REPORTED THAT: PATIENT IS EXPERIENCING PAIN SINCE HAVING SURGERY. PAIN HAS INCREASED STEADILY ALSO SINCE HAVING SURGERY. PATIENT STATES HAVING DIFFICULTY WALKING AND IS UNABLE TO DO ANY HEAVY LIFTING. PATIENT ALSO STATES THAT SHE IS ALWAYS COLD ON THE LEFT SIDE. PATIENT IS SCHEDULED TO HAVE BLOOD TEST ON (B)(6), 2013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26038	LRG TAP PRI MOD NCK 0DEG 34MM	IMPLANT	LZO	STRYKER ORTHOPAEDICS-MAHWAH		38248501

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Other