MAUDE Adverse Event Report: BIOMET UK LTD. RLOC-X ARCOMXL H/W 54/36MM 24; HIP PROTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Refer also to report - 3002806535-2019-00247.Report source: foreign - event occurred in (b)(6).Investigation is on-going.When investigation has been completed, follow up mdr report will be submitted.

Event Description

Revision due to loosening.

Event Description

Revision due to loosening.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2019-00247-1.Products have been returned to biomet uk ltd for evaluation and were forwarded to the complaints product evaluation engineer for investigation.A 36 mm diameter biolox delta ceramic femoral head and a ringloc-x arcomxl hi-wall liner were revised after approximately 8 weeks due to reported loosening.The ringloc-x arcom xl hi-wall liner displays adverse wear on the non-articulating surface and two deformed castellations on the rim.The liner has unidirectional grooves on the surface that articulates with the shell.Furthermore, the biolox delta ceramic head shows a large region of metal transfer.There is a large region of dark metal transfer which covers approximately 20 percent of the bearing surface.These observations suggest that the liner has dislocated from the shell in vivo, which may have led to unintended articulation between the ceramic head and the inner surface of the acetabular shell.However, this cannot be confirmed without pre-revision radiographs.Items xl-053654 and 650-0836 are compatible with each other.Post-primary radiographs have also not been provided with (b)(4), therefore, an assessment of the initial component sizing, positioning and alignment could not be performed.No device or manufacturing deficiencies have been identified that could cause the reported event.No relationship of function or performance of the device has been established to the reported event.The manufacturing history records (mhrs) of the returned components have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.Device history record (dhr) was reviewed and no discrepancies were found.No other similar complaints have been reported against the item.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: RLOC-X ARCOMXL H/W 54/36MM 24
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8403131
• MDR Text Key: 138208465
• Report Number: 3002806535-2019-00248
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• 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: XL-053654
• Device Lot Number: J3420331
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention