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 Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: the patient had a right total hip arthroplasty on (b)(6) 2022.Subsequently, on (b)(6) 2022, the patient leaned over and dislocated the right hip.A closed reduction was performed.No further complications were reported.
Additional Manufacturer Narrative
(b)(4).Initial report: the client has indicated that the product will not be returned to zimmer biomet for an investigation.Associated products: medical product: g7 vit e neutral lnr 36mm e catalogue number: 30103605 lot number: 65207737; medical product: g7 pps ltd acet shell 52e catalogue number: 010000663 lot number: 7085907; medical product: bone screw self-tapping 6.5 mm dia.30 mm length catalogue number: 00625006530 lot number: j7146596; medical product: echo por fmrl lat nc 8x120mm catalogue number: 192108 lot number: 377850.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 had a right total hip arthroplasty on 8-feb-2022.Subsequently, on 27-feb-2022, the patient leaned over and dislocated the right hip.Closed reduction was performed.No further complications were reported.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the manufacturing history record confirms that the device & packaging was processed and verified in line with the specification and quality characteristics and was completed as defined by zimmer biomet.A review of the certificate of conformance from ceramtec gmbh confirms conformance to specification.The device is used for treatment.The reported product was reviewed with the associated product for compatibility with no issues noted.Complaint history review for 650-0661 identified one (1) previous complaint.Medical records/radiographs were not provided.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 definitive 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.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 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: 14140320
• Report Number: 3002806535-2022-00221
• Device Sequence Number: 15010483
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: 00887868271175
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/19/2022

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: 3035189
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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: 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female