FDA Adverse Event Injury Summary report: N

RINGLOC-X E1 H/W 56/36MM

MDR report key: 24996931 · Received April 27, 2026

Report

Report Number: 3002806535-2026-00163
Event Type: Injury
Date Received: April 27, 2026
Date of Event: September 16, 2025
Report Date: April 27, 2026
Manufacturer: BIOMET UK LTD.
Product Code: LPH
UDI-DI: 05019279297245
PMA / PMN Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: DA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

(B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024519848. D10: 650-0389, BI-METRIC COCR 9X125MM T1, LOT: 6095812. 11-363661, 36MM COCR MOD HD -3MM, LOT: 179580. 131356, EXC ABT RNGLC-X SHELL PC 056MM, LOT: 6115071. G2: FOREIGN ¿ DENMARK. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190660. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWENTY-SEVEN YEARS POST IMPLANTATION DUE TO BEARING WEAR AND LOOSENING OF THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT HAS BEEN REPORTED UNDER INCORRECT MFR NUMBER: MFR WARSAW ZIMMER: 0001822565-2025-03975.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
501264	RINGLOC-X E1 H/W 56/36MM	HIP PROTHESIS	LPH	BIOMET UK LTD.		6050081	05019279297245

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention\| H	SEE H11 NARRATIVE.