FDA Adverse Event Injury Summary report: N

GLENOID, PE WITH PEG, SMALL

MDR report key: 9409890 · Received December 4, 2019

Report

Report Number: 1220246-2019-01454
Event Type: Injury
Date Received: December 4, 2019
Date of Event: November 14, 2019
Report Date: February 11, 2020
Manufacturer: ARTHREX, INC.
Product Code: KWS
UDI-DI: 00888867057319
PMA / PMN Number: K083435
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

COMPLAINT NOT CONFIRMED. THE DEVICE WAS FOUND TO BE WORN AND/OR DAMAGED ON THE SUPERIOR POSTERIOR AND INFERIOR SURFACES AND EDGES. A LIKELY CAUSE OF THE WEAR AND/OR DAMAGE IS THE HUMERAL HEAD NOT BEING CENTERED. THE INFORMATION RECEIVED REGARDING THE EVENT IS NOT SUFFICIENT TO ADDRESS THE PAIN ALLEGATION.

Additional Manufacturer Narrative · 1

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT HAD AN ECLIPSE SURGERY ON THE (B)(6) 2016. FOR A WHILE EVERYTHING WAS FINE AND NO COMPLAINTS, BUT THEN ALL OF A SUDDEN SHE FELT PAIN. THE SURGEON DECIDED ON A REVISION SURGERY WHERE THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED: AR-9105-01, AR-9341-16 (1295154707), AR-9300-41CPC (14.641), AR-9301-01 (13.225) A NEW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. NO FURTHER INFORMATION RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1205569	GLENOID, PE WITH PEG, SMALL	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	KWS	ARTHREX, INC.	GLENOID, PE WITH PEG, SMALL	UNK	00888867057319

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Other