MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA MODULAR CERAMIC FEM HD 36/-3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Failure of Implant (1924)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Tprlc 133 t1 pps so 20x160mm, item# 51-103200, lot#7244589.Hxpe liner neut 58 ll x 36, item# 00-8751-013-36, lot# 65501354.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported during the revision, that the stem would not disengage from the head.The stem and that head were removed and new ones were used to complete the procedure.The approximate surgical delay was around ninety minutes.Attempts have been made and no further information is available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified metal transfer to the ceramic head which could be from both the dislocation and from the instruments where the head was attempted to be removed from the stem.The head is still attached to the stem and there is damage to the neck of the stem.A review of the device manufacturing records confirmed no abnormalities or deviations.A review of the raw material certificate confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.It should be noted however that the same device is included in an additional complaint on a post-op head dislocation and reported in mfr 3002806535-2024-00104.Radiographs were provided and reviewed by a radiologist.The review identified that there is a left hip arthroplasty with a superolateral dislocation.The femoral head is anteriorly displaced on the cross-table lateral view, but the cup is not well visualized.There is no fracture.Other than the dislocation, no other implant failure is identified.The cup abduction angle measures approximately fifty-three degrees, at the upper limit of normal.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 MODULAR CERAMIC FEM HD 36/-3MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 18928527
• MDR Text Key: 338694987
• Report Number: 3002806535-2024-00105
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0660
• Device Lot Number: 3159543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2023
• 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: SEE H10 NARRATIVE
• Patient Sex: Male