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	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: occasional pain on the top of the right hip - sharp pain.Trochanteric region.No further patient outcome.
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in europe: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products associated products: medical product: g7 bonemaster ltd acet shl 56f, catalog no.: 010000705, lot no.: 3818257.Medical product: g7 hi-wall e1 liner 36mm f, catalog no.: 010000936, lot no.: 3819969.Medical product: tprlc 133 fp type1 bm so 10.0 t1, catalog no.: 51-110100, lot no.: 3581766.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The product will not be returned to zimmer biomet for investigation, as it remains implanted.X-rays or medical notes have not been provided.The investigation has been limited to the information provided, a review of the device history records, and a complaint history search.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 additional similar complaints for the reported item number and one additional complaint for the reported item and lot combination.This device is used for treatment.The implants used have been confirmed to be compatible.The part and lot combination was not associated with any recalls at the time the search was conducted.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event cannot be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.
Event or Problem Description
It was reported that a patient underwent an initial right hip arthroplasty on (b)(6) 2016.Subsequently, it was reported on (b)(6) 2021, that the patient was experiencing occasional pain on the top of the right hip and sharp pain in trochanteric region.Medication provided.

• 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: 12915734
• Report Number: 3002806535-2021-00518
• Device Sequence Number: 17572484
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: 00887868271175
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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 Expiration Date: 05/06/2026
• Device Model Number: N/A
• Device Catalogue Number: 650-0661
• Device Lot Number: 2016050122
• 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: 11/22/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2016
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG