MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RINGLOC+ REPLACEMENT RING SZ21; PROSTHESIS, HIP

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has not been returned for evaluation at this time.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported two locking rings were damaged intraoperatively.No complications or delays reported.No further information made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: comprehensive reverse shoulder humeral tray with locking ring, catalog#: 115370, lot #: 327330.Arcom xl humeral bearing, catalog#: xl-115363, lot#: 935090.Comprehensive reverse shoulder glenosphere, catalog#: 115310, lot#: 455910.Comprehensive locking screw, catalog#: 180550, lot#: 131120.Comprehensive locking screw: catalog#: 180550, lot#: 494290.Comprehensive locking screw, catalog#: 180550, lot#: 211660.Comprehensive locking screw, catalog#: 180551, lot#: 772110.Comprehensive reverse central screw, catalog#: 115394, lot#: 485450.Comprehensive primary mini stem: catalog#: 113629, lot#: 392260.Comprehensive reverse baseplate + adapter, catalog#: 010000589, lot#: 206570.Comprehensive reverse drill, catalog#: 405889, lot#: 873170.Comprehensive reverse drill, catalog#: 405883, lot#: 432500.Comprehensive reverse shoulder steinmann pin, catalog#: 405800, lot#: 820130.Steinmann pin, catalog#: 406669, lot#: 063830.Reported event was unable to be confirmed due to limited information received from the customer.The locking ring from item number 115370, lot number 327330 was returned and item number 106021, lot number 684850 was discarded.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported that during a total shoulder arthroplasty, two locking rings were damaged intraoperatively while trying to assemble the humeral bearing to the tray.In the first attempt, the assembly tool was not used, however, on the second attempt with the replacement locking ring the tool was used.In both cases, the locking ring bent.No complications or delays reported.A new tray was opened and utilized to complete the procedure.No further information made available at this time.

• Brand Name: RINGLOC+ REPLACEMENT RING SZ21
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6819812
• MDR Text Key: 83747149
• Report Number: 0001825034-2017-06204
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 106021
• Device Lot Number: 684850
• Other Device ID Number: (01) 0 0880304 45517 7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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
• Patient Age: 69 YR