MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/0MM T1; BIOLOX DELTA CERAMIC FEM HD

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Joint Dislocation (2374); Subluxation (4525)

Event Date 12/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: the client has indicated that the product will not be returned to zimmer biomet for an investigation, as it remains implanted.Associated products: medical product: echo por fmrl lat nc 12x140mm, catalogue number: 192112, lot number: 851160; medical product: g7 pps ltd acet shell 56f, catalogue number: 010000665, lot number: 3694265.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-0214.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: the patient underwent an initial right total hip arthroplasty on (b)(6) 2016.Subsequently, he had a manipulation under anaesthesia (mua) on (b)(6) 2021 due to dislocation and subluxation.Components remained implanted.

Event Description

It was reported that: the patient underwent an initial right total hip arthroplasty on (b)(6) 2016.Subsequently, had a manipulation under anaesthesia (mua) on (b)(6) 2021 due to dislocation and subluxation.Components remained implanted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: adequate photographs have not been provided and product the 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.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.These devices are used for treatment.A compatibility review shows that the implants for this event are compatible.A review of complaint history identified no additional similar complaints about the reported item: 650-1162 and no additional complaints about the reported item and lot combination / additionally no similar complaints about the reported item: 110003619 and no additional complaints about the reported item and lot combination medical records or x-rays have not been provided.The likely condition of the devices when they left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided and the product has 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.It has been confirmed that these implants are not within the scope or subject of any field actions or recalls which could be attributed to the reported events.Corrective or preventative action is not required.The root cause of the reported event cannot be determined with the information provided.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00214-1.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 32/0MM T1
• Type of Device: 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: 14083377
• MDR Text Key: 289062760
• Report Number: 3002806535-2022-00213
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271564
• UDI-Public: 00887868271564
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1162
• Device Lot Number: 2015091218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 110 KG