MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 40MM; BIOLOX DELTA CER OPT HD LG DIA

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Unintended Movement (3026); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Associated products: medical product: g7 neutral e1 liner 40mm f catalog no.: 010000864, lot no.: 6544595; medical product: g7 osseoti multihole 56mm f catalog no.: 110010266, lot no.: 6578075; medical product: echo por fmrl red nc 13x145mm catalog no.: 192413, lot no.: 674160; medical product: bone screw self-tapping 6.5 mm dia.15 mm length catalog no.: 00625006515, lot no.: 64492557; medical product: bone screw self-tapping 6.5 mm dia.40 mm length catalog no.: 00625006540, lot no.: 64302847; medical product: cer option type 1 tpr sleve -3 catalog no.: 650-1065, lot no.: 2959057.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.
Event or Problem Description
It was reported that an initial right total hip arthroplasty was performed (b)(6) 2013.Subsequently, the patient was revised (b)(6) 2019 due to metal related pathology.A few months later, the patient developed instability with recurrent dislocations.A small nondisplaced transverse acetabular fracture was identified on x-ray.The patient underwent a second revision on (b)(6) 2020.During the revision, impingement was noted as well as disruption of the previous capsular repair.The initial stem and revision shell were left intact.The head and liner were replaced without complication.
Additional Manufacturer Narrative
(b)(4).Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 13 similar complaints reported with the item.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device not returned.
Event or Problem Description
It was reported that an initial right total hip arthroplasty was performed (b)(6) 2013.Subsequently, the patient was revised (b)(6) 2019 due to metal related pathology.A few months later, the patient developed instability with recurrent dislocations.A small nondisplaced transverse acetabular fracture was identified on x-ray.The patient underwent a second revision on (b)(6) 2020.During the revision, impingement was noted as well as disruption of the previous capsular repair.The initial stem and revision shell were left intact.The head and liner were replaced without complication.

• Brand Name: CER BIOLOXD OPTION HD 40MM
• Common Device Name: BIOLOX DELTA CER OPT HD LG DIA
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12376254
• Report Number: 3002806535-2021-00358
• Device Sequence Number: 11746893
• Product Code: OQG
• UDI-Device Identifier: 00887868271403
• UDI-Public: 00887868271403
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1058
• Device Lot Number: 2963349
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 72