MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOMXL RLC 32MM 10 DEG SZ23; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products : item #: unknown, head lot #: unknown, item #: unknown, liner lot #: unknown, item #: unknown, cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It has been reported that an acetabular liner was implanted during the initial surgery trial fit.The surgeon went through range of motion and hip was dislocating too easily, so the liner was removed.The fault was noticed once removed and implant was isolated.Attempts were made to obtain additional information; however, none was available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).An additional mdr report was filed for this event, please see associated report: 0001825034 -2020 - 02078.Reported event was confirmed by visual inspection of device.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A arcomxl rlc 32mm 10 deg sz23, part # xl-105833 from lot 959900, was returned and evaluated against the complaint.Visual inspection found heavy damage to the locking groove.Scratching was observed on the outer radius and the rim of the liner.Indentations were observed that appear to have been made by a tool gripping the liner during explantation.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: ARCOMXL RLC 32MM 10 DEG SZ23
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9744113
• Report Number: 0001825034-2020-00799
• Device Sequence Number: 16764927
• Product Code: LZO
• UDI-Device Identifier: 00880304433441
• UDI-Public: 00880304433441
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2023
• Device Model Number: N/A
• Device Catalogue Number: XL-105833
• Device Lot Number: 959900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 56 YR