MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; BIOLOX DELTA CERAMIC OPTION HD

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.The product has been requested to be returned to zimmer biomet for an investigation.Concomitant medical products: medical product: g7 dual mobility liner 46mm g; catalogue number: 110024465; lot number: 371300.Medical product: unknown dm poly liner; catalogue number: unknown dm poly liner; lot number: unknown.Medical product: arcos con sz b std 60mm; catalogue number: 11-301302; lot number: 360360.Medical product: 3.2mmx30mm rnglc+ acet drl bit; catalogue number: 31-323230; lot number: 082320.Medical product: arcos 18x150mm spl tpr dist; catalogue number: 11-300818; lot number: 221260.Medical product: cer option type 1 tpr sleve -6; catalogue number: 650-1064; lot number: 3032903.Medical product: g7 dual mobility liner 46mm g; catalogue number: 110024465; lot number: 110024465.Medical product: vivacit-e dm bearing 28x46mm; catalogue number: 110031013; lot number: 65016432.Medical product: bone scr 6.5x35 self-tap; catalogue number: 00625006535; lot number: j6851898.Medical product: bone scr 6.5x35 self-tap; catalogue number: 00625006535; lot number: j6851905.Medical product: g7 osseoti multihole 58mm g; catalogue number: 110010267; lot number: 6512782.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 patient underwent a revision of the right hip on (b)(6) 2021, due to unknown reasons.Subsequently, a revision procedure due to dislocation (femoral head became disassociated from dm poly liner) was performed on (b)(6) 2022.No further outcome.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: the product has not been returned for evaluation, therefore the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.The device is used for treatment.A dhr review identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified 14 similar complaints about the reported item number, and no additional complaints for the same item and lot combination for 3 years prior to the notification date it has been confirmed that the item is not within the scope or subject of any field actions or recalls which could be attributed to the reported event.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.We have not been provided with x-rays or any supporting documentation which could provide additional information a definitive root cause cannot be determined.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review did not identify any issues.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 will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
The patient became dislocated and could not be reduced through close reduction.Had to open and found femoral head became disassociated from dm poly liner.Dm construct removed and freedom construct put in place.No further outcome.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Common Device Name: BIOLOX DELTA CERAMIC OPTION HD
• 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: 13480258
• Report Number: 3002806535-2022-00053
• Device Sequence Number: 5247824
• Product Code: LZO
• UDI-Device Identifier: 00887868271465
• UDI-Public: 00887868271465
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 03/08/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 3062495
• Was Device Available for Evaluation?: No
• 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: 01/16/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic