MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RINGLOC MALLORY HEAD HIP SYSTEM ACETABULAR SHELL 46MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult To Position (1467); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).

Event Description

It was reported that during a hip procedure, the cup inserter disengaged from the cup during impaction.When attempting to reassemble, an audible noise was noted, and the inserter could not be assembled with the cup.Another cup was used to complete the procedure.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.M/h 3hole rlc shl nrs 46mm/l22 was returned for evaluation, but inserter was not.Threaded part of the shell found to be damaged and can be verified with visual inspection.Outer diameter of the cup exhibits foreign material, while the inner diameter exhibits scratches.These scratches likely occurred during assembly of inserter with the cup.Threaded part of the shell was viewed under a magnifying glass and was confirmed to be cross-threaded.The inserter could not be inserted onto the cup due to this damage.Inserter and surgical notes were not provided device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further actions are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: RINGLOC MALLORY HEAD HIP SYSTEM ACETABULAR SHELL 46MM
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6094647
• MDR Text Key: 59714588
• Report Number: 0001825034-2016-04666
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 13-104146
• Device Lot Number: 351410
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• 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 Outcome(s): Required Intervention