MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGEN/RNGLC+ LTD 52MM SZ 23; FIXATION, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467); Fitting Problem (2183); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2014

Event Type  malfunction  

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The product evaluation states, "the ring appears to be sprung open, creating a larger than normal gap at the opening.The gap is specified on the drawing to be.005"/.060", it was measured around.140".Deformation such as that displayed by the ring can only occur when the ring is out of the shell because it would be too constrained while in the shell to open that far.It is possible that the deformation could occur while the ring is being removed from the shell if care is not taken during the removal.The locking ring that was returned would not have been able to move freely when installed in a cup." the ring undergoes thorough inspection as it arrives at biomet, per procedure, and after it has been assembled, there is a further inspection to assure that it fits correctly in the cup.Per internal procedure, each locking ring is checked to make sure it is able to move freely after assembly.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.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

Locking ring would not lock liner into place in a ringloc+ cup.The liner would not remain seated inside cup after attempting to lock in place with a locking ring.

• Brand Name: REGEN/RNGLC+ LTD 52MM SZ 23
• Type of Device: FIXATION, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6926398
• MDR Text Key: 89941263
• Report Number: 0001825034-2017-08071
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: PT-116052
• Device Lot Number: 729620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1