MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 40MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 650-1066, lot number:2959139, brand name: ceramic taper sleve; catalog number: 650-1058, lot number: 2959718, brand name: cer bioloxd option hd; catalog number: 010000666, lot number:6490955, brand name: g7 acetabular shell; catalog number: 51-106160, lot number: 6462388, brand name: taperloc stem.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 during an initial hip arthroplasty, the liner would not seat properly into the shell.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Udi# (b)(4).Complaint sample was evaluated and the reported event was not confirmed.The reported device was returned and evaluated.Upon visual inspection the locking feature has been damaged due to impaction.No dimensional analysis can be performed as product has been impacted.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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: G7 NEUTRAL ARCOMXL LNR 40MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8740970
• MDR Text Key: 150879652
• Report Number: 0001825034-2019-02751
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000748
• Device Lot Number: 6475619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 32 YR