FDA Adverse Event Injury Summary report: N

OMNIFIT SER. II INSERT-10 DEG.

MDR report key: 4221410 · Received November 3, 2014

Report

Report Number: 0002249697-2014-04100
Event Type: Injury
Date Received: November 3, 2014
Date of Event: October 7, 2014
Report Date: October 7, 2014
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: LPH
PMA / PMN Number: K943054
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AN EVENT REGARDING WEAR INVOLVING AN OMNIFIT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT COULD NOT CONFIRM THE EVENT. HE DETERMINED THAT X-RAYS, PRIMARY OP REPORTS AND EXAMINATION OF EXPLANTED COMPONENTS ARE NEEDED TO FURTHER INVESTIGATE. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING X-RAYS, PRIMARY OP REPORTS AND EXAMINATION OF EXPLANTED COMPONENTS ARE NEEDED TO FURTHER INVESTIGATE THE EVENT.

Additional Manufacturer Narrative · 1

AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT WAS REVISED ON A HIP DUE TO POLYETHYLENE WEAR.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT WAS REVISED ON A HIP DUE TO POLYETHYLENE WEAR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
701618	OMNIFIT SER. II INSERT-10 DEG.	IMPLANT	LPH	STRYKER ORTHOPAEDICS-MAHWAH		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention