MAUDE Adverse Event Report: BIOMET UK LTD. M/H SLD/APX HLE RNGLC SHL 54MM; MALLORY HEAD PC CUP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in europe: (b)(6).Concomitant medical products: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Associated products: medical product: epoly 32mm rlc lnr mrom sz24, catalog no.: ep-105934, lot no.: 490490.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during surgery the liner did not fit the cup.A new liner was not available.A new cemented cup was implanted after removal of the non-cemented cup.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: it was reported, that: during surgery, the liner did not fit the cup.A new liner wasn¿t available.A new cemented cup was implanted after the removal of the uncemented cup.Patient outcome- prolonged surgery.A visual inspection of the m/h solid/apex hole ringloc shell 54mm assembly (item: 11-104054 lot: 6092384) shows damage to the location tabs, front face, ring location groove and internal spherical dim.The locking ring which is still located in the shell is damaged and distorted.This device is used for treatment.The shell and liner are compatible with each other as they are both sz24.A dimensional inspection could not be carried out due to the damage to the shell most likely caused during implantation or explantation.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.The definitive root cause of this event cannot be determined with the available information.The investigation is completed based on currently available information.If any additional information becomes available, then the complaint will be reopened and investigated.A review of the complaints database shows that we have received no reported events for implant would not assemble with a mating implant for the same item number ¿11-104054¿ prior to the reported event.It was confirmed that the reported harm/hazardous situation, incorrect product assembly, is addressed in the associated risk management file for the reported product however as the failure mode associated with the reported event is unknown, a specific risk line item cannot be identified.No corrective or preventive action is required at this time.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be generated accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported, that: during surgery, the liner did not fit the cup.A new liner was not available.A new cemented cup was implanted after the removal of the non-cemented cup.

• Brand Name: M/H SLD/APX HLE RNGLC SHL 54MM
• Common Device Name: MALLORY HEAD PC CUP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12670959
• Report Number: 3002806535-2021-00457
• Device Sequence Number: 16520754
• Product Code: LZO
• UDI-Device Identifier: 00887868307553
• UDI-Public: 00887868307553
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-104054
• Device Lot Number: 6092384
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown