MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 28/-3MM T1; BIOLOX DELTA CERAMIC FEM HD

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: the patient underwent a left hip procedure on (b)(6) 2021.Subsequently, the patient suffers from hip pain and stiffness as well as limited exercise.The onset of complications was (b)(6) 2021.Patient outcome: a prolonged episode of care.
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: the patient underwent a left hip procedure on (b)(6), 2021.Subsequently, the patient suffers from hip pain and stiffness as well as limited exercise.The onset of complications was (b)(6) 2021.Patient outcome: a prolonged episode of care.23 mar 2022 addi medical report received.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: a review of the device history records identified no (related) deviations or anomalies during manufacturing  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Devices are used for treatment the reported product was reviewed for compatibility with the linked complaints with no issues noted.A review of complaint history found no additional related issues for this item and the reported part and lot combinations.Medical records were not provided.A definitive root cause could not be determined.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DELTA CER FEM HD 28/-3MM T1
• Common Device Name: BIOLOX DELTA CERAMIC FEM 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: 13665923
• Report Number: 3002806535-2022-00091
• Device Sequence Number: 5466421
• Product Code: LZO
• UDI-Device Identifier: 00887868271533
• UDI-Public: 00887868271533
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 650-1159
• Device Lot Number: 3066346
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 87 KG