FDA Adverse Event Injury Summary report: N

LATERALIZD HUM CUP DIA 36+6MM

MDR report key: 7406626 · Received April 9, 2018

Report

Report Number: 1818910-2018-56913
Event Type: Injury
Date Received: April 9, 2018
Date of Event: March 12, 2018
Report Date: March 12, 2018
Manufacturer: DEPUY FRANCE SAS - 3003895575
Product Code: KWS
UDI-DI: 10603295170471
PMA / PMN Number: K021478
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEVICE HISTORY LOT: PRODUCT CODE 4CHL636, LOT NUMBER 1894788. DEVICE HISTORY REVIEW: THE DHR ANALYSIS OF THE BATCH 1894788 SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT REGARDING ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR NON-CONFORMANCE. THIS BATCH WAS MANUFACTURED IN JUNE 2005. 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 THAT THE NEW 9MM CTA HUMERAL SPACER WOULD NOT SCREW INTO THE IMPLANTED CEMENTED MONO BLOCK STEM SO THE SURGEON CHOOSE TO CUT THE THREADS OFF THE IMPLANT AND ONLY USE THE TAPER AS A LOCKING MECHANISM. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
252077	LATERALIZD HUM CUP DIA 36+6MM	DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP	KWS	DEPUY FRANCE SAS - 3003895575		1894788	10603295170471

Patients

Seq	Age	Sex	Outcome	Treatment
1