MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOMXL 32MM +3 MROM LNR SZ 22; HIP PROSTHESIS

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon could not get liner seated properly.The locking ring would not slide properly.After two tries the surgeon requested a new liner and it seated properly.Attempts have been made, and no further information has been provided.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection there was visible damage to both the scallops and to the outside radius.The scallops show signs of impaction.There are two small indentations on the outside radius.Small indentation was found along the locking feature.No further analysis done as the poly liner was impacted.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 32MM +3 MROM LNR SZ 22
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7596621
• MDR Text Key: 111012093
• Report Number: 0001825034-2018-03927
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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: Physician
• Device Expiration Date: 07/17/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-108222
• Device Lot Number: 209780
• Other Device ID Number: (01) 0 0880304 65148 7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ITEM # PT-116050, CUP, LOT # 557370
• Patient Age: 80 YR