MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE -3; CER BIOLOXD OPT TYPE 1 TPR SLV

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report: the client has indicated that the product is in process of being returned to zimmer biomet for an investigation.Associated products: medical product: arcomxl 36mm rlc lnr +5mm sz23 catalogue number: xl-156233 lot number: 414730; medical product: 36mm cocr mod hd std catalogue number: 11-363662 lot number: j7161372; medical product: e-poly 36mm +3 hiwall lnr sz23 catalogue number: ep-108323 lot number: 268600.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00216.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that: a ceramic head exchange for a cobalt chrome head (cocr).The doctor thinks the ceramic taper may have disengaged from the taperloc stem and it could have been pistoning.I would like to hear back if anything is found about the implants.Primary surgery was done on (b)(6) 2013.Patient outcome: revision.
Additional Manufacturer Narrative
(b)(4).This follow-up document is being submitted to relay supplemental information.Supplemental information acquired: patient details additional associated item.D10 associated products: medical product: taperloc pc 11mm t1.Catalogue number: 103205.Lot number: 640580.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00216-1.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.
Event or Problem Description
It was reported, that: a ceramic head exchange for a cobalt chrome head (cocr).The doctor thinks the ceramic taper may have disengaged from the taperloc stem and it could have been pistoning.I would like to hear back if anything is found about the implants.Primary surgery was done on feb 12, 2013.Patient outcome: revision.26 apr 2022 addi.The primary case was by dr (b)(6), performed at (b)(6).Stem ref 103205 lot 640580.No invoices or sticker sheets are available.Bone quality was good and the patient is a fit male (62.6 kg).Dob 5-8-64.No contributing conditions.X-rays the post-op x-rays are immediate post-op.The pre-op x-ray is not directly post-op of the primary but sometime in between primary and revision.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.A visual inspection shows that there are metal transfer marks on the bottom surface of the head along with dents on the edge of the taper adaptor.These were most caused by the explantation process.The taper looks to be in good condition with no scoring marks visible.Dimensional analysis shows the the product is conforming to specification.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed.Device history record was reviewed and no discrepancies related to the reported event were found.The root cause of the reported event cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -3
• Common Device Name: CER BIOLOXD OPT TYPE 1 TPR SLV
• 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: 14110800
• Report Number: 3002806535-2022-00217
• Device Sequence Number: 5277245
• Product Code: LZO
• UDI-Device Identifier: 00887868271472
• UDI-Public: 00887868271472
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 650-1065
• Device Lot Number: 464050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 06/21/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 04/28/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2012
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 62 KG