MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; BIOLOX DELTA CER OPT HD LG DIA

Model Number N/A

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

Patient Problem Joint Dislocation (2374)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Combined initial/final report.This complaint was originally based on a 28mm ceramic head produced in usa so all previous reports were filed by the us zb team.Now the product has been identified as a 36mm, which is produced in (b)(6), it is now under (b)(6) control.The product has already been returned to zimmer biomet.Associated products: medical product: cer option type 1 tpr sleve +3, catalogue number: 650-1067, lot number: unknown.Complaint summary: investigation reopened as the product has now been returned.A visual inspection of the returned product shows this ceramic head to be a 36mm and not a 28mm as reported in the complaint, the ceramtec # is r36.The head shows signs of metal transfer on its surface indicating that articulation has taken place, most likely against the surface of the shell.There is also damage to the edge of the tapered adapter most likely caused whilst removing during the revision.Ceramtec coc review-: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.A review of complaint history identified an additional 1 similar complaint about the reported item 650-1057 (lot number unconfirmed).Unable to perform complaint history for unknown shell as item/lot number is unknown.It has been confirmed that implant 650-1057 is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.The likely condition of the devices when they left zimmer biomet is conforming to the specification.The reported event has not been confirmed.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.Multiple mdr reports were filed for this event previously, please see associated report numbers: 0001825034-2019-01678, 0001825034-2019-01678-1, 0001825034-2019-01678-2.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly and the complaint reopened.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: a patient¿s legal counsel reported that the patient underwent left total hip arthroplasty on (b)(6) 2017.Legal counsel further reports patient underwent a revision procedure on (b)(6) 2018, due to dislocation and failed hip.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Type of Device: BIOLOX DELTA CER OPT 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: 14405778
• MDR Text Key: 291703605
• Report Number: 3002806535-2022-00243
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• 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: 650-1057
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female