MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X49MM; PROSTHESIS, HIP

Catalog Number 11-165222

Device Problems Difficult to Insert (1316); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the ring inside the head is loose and does not allow the liner to be implanted properly.There was no harm or health consequences to the patient.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.A ringloc bi-polar 28x49mm, part # 11-165222 from lot 249980, was returned and evaluated against the complaint.No identifiers are visible to be verified against the complaint.The returned assembly appears to be fully seated.The liner rotates freely within the cup.By viewing into the cut outs, it can be seen that the locking groove of the liner is engaging the ring.While holding the shell in 1 hand, the technician attempted to disengage the assembly, by pulling on the lip of the liner with a thumb from the other hand.The assembly could not be physically disengaged in the lab.Small nicks and dings are present around the rim of the cup.A small sliver of poly was observed inside one of the cutouts of the liner.Dhr was reviewed and no discrepancies related to the reported event were found.The investigation could not verify or identify any evidence of product contribution to the reported problem.The complaint could not be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: RINGLOC BI-POLAR 28X49MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17354745
• MDR Text Key: 319616647
• Report Number: 0001825034-2023-01692
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304002227
• UDI-Public: (01)00880304002227(17)271106(10)249980
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11-165222
• Device Lot Number: 249980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1