MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA LNR 36MM 54-56MM; BIOLOX DELTA XLW-18 LINER

Model Number N/A

Device Problems Break (1069); Fracture (1260); Biocompatibility (2886); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Associated products: medical product: taperloc por fmrl 13.5x147, catalog no.: 103207, lot no.: 200640.Medical product: delta ceramic fem hd 36/-3mm, catalog no.: 650-0660 , lot no.: 3035752.Medical product: exceed abt 3hl shell 44/56mm , catalog no.: 124456, lot no.: 3083090.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Patient underwent a left hip procedure on (b)(6) 2013.Subsequently, within 3 years the patient began experiencing pain in the left hip and presented to physician on (b)(6) 2019 where x-rays were taken and showed the liner had cracked and the head was wearing directly on the shell.On (b)(6) 2019, the patient underwent a revision to replace the implant.During the surgery, significant metallosis was noted.The surgeon was unable to complete the surgery at that time and patient was brought back to the operating room on (b)(6) 2019 to complete the surgery successfully.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Devices are used for treatment.No compatibility issues were noted.Review of the device history records identified no related deviations or anomalies during manufacturing related to the reported event a review of complaint history was assessed for three years prior to the notification date and identified (5) total complaints including the initiating complaint for item #650-0795.There was (1) additional complaint against the lot #3010403 which is the initiating complaint.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that the patient underwent a left hip procedure on (b)(6) 2013.Subsequently, within 3 years the patient began experiencing pain in the left hip and presented to physician on (b)(6) 2019, where x-rays were taken and showed the liner had cracked and the head was wearing directly on the shell.On (b)(6) 2019, the patient underwent a revision to replace the implant.During the surgery, significant metallosis was noted.The surgeon was unable to complete the surgery at that time and patient was brought back to the operating room on (b)(6) 2019 to complete the surgery successfully.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.Medical records were provided and reviewed by a health care professional.The review identified the following: the patient underwent spinal anesthesia, revealing significant metallosis and a degenerated ceramic acetabulum liner with a scratched ceramic head.Penetration of the ceramic head caused metallosis, leading to tissue debridement.Significant lysis medially and osteolysis along the proximal femur were observed.The stem was removed via osteotomy, with stabilization using a cerclage cable.A longer stem is planned for a later date.The patient was closed with intent to return for further interventions.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA LNR 36MM 54-56MM
• Type of Device: BIOLOX DELTA XLW-18 LINER
• 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: 12258097
• MDR Text Key: 264698653
• Report Number: 3002806535-2021-00327
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 05019279114160
• UDI-Public: (01)05019279114160(17)230430(10)3010403
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-0795
• Device Lot Number: 3010403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male