MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/0MM; BIOLOX DELTA CER FEM HD LG DIA

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital policy.Associated products: medical product: g7 vit e neutral lnr 36mm f, catalog no.: 30103606, lot no.: 65051774.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Hospital policy.
Event or Problem Description
It was reported that the patient underwent left total hip arthroplasty (b)(6) 2021.Subsequently, patient underwent a revision procedure (b)(6) 2021 due to dislocation/instability.The liner and head were removed and replaced with duel mobility.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: 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.Without the opportunity to examine the complaint item, a definitive root cause cannot be determined due to insufficient information.The devices are used for treatment.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified no additional similar complaints for the reported item number in the last 3 years, and no additional complaints for the same item and lot combination.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 reported event.A definitive root cause cannot be determined.The likely condition of the devices when they left zimmer biomet is conforming to 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.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text : hospital policy.
Event or Problem Description
It was reported that the patient underwent left total hip arthroplasty (b)(6) 2021.Subsequently, patient underwent a revision procedure (b)(6) 2021 due to dislocation/instability.The liner and head were removed and replaced with duel mobility.

• Brand Name: DELTA CERAMIC FEM HD 36/0MM
• Common Device Name: BIOLOX DELTA CER FEM HD LG DIA
• 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: 12622856
• Report Number: 3002806535-2021-00444
• Device Sequence Number: 1442974
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: 00887868271175
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 650-0661
• Device Lot Number: 3050950
• 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: 10/02/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female