MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 36MM H M H; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03588.

Event Description

It was reported during an initial tha, that after the g7 cup was implanted, the doctor tried to implant two g7 high wall liners (a 36 mm size h and a 32 mm) in patient but with the two liners were unable to be fully seated in place, even with a 36 or 32 mm liner impactor.After attempts, the doctor decided to use a ceramic liner and it worked.No adverse events have been reported as a result of the malfunction sales rep indicates that no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6 -no product was returned or pictures provided; visual and dimensional evaluations could not be performed.- review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.-a definitive root cause cannot 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.

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.The following sections were updated/corrected updated: d9; h2; h3; h6 device was returned and evaluated.Upon visual inspection the locking features of both devices have visible damage.There is no visible damage to the outside radius.The additional information does not change the outcome of the previous investigation.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.

Event Description

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

• Brand Name: G7 HI-WALL ARCOMXL LNR 36MM H M H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10567990
• MDR Text Key: 207982572
• Report Number: 0001825034-2020-03587
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526112
• UDI-Public: (01)00880304526112(17)240805(10)6605127
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2021

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: 010000821
• Device Lot Number: 6605127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/27/2020; 03/03/2021
• Supplement Dates FDA Received: 10/28/2020; 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET G7 LNR 36MM CAT#010000821 LOT#6475655; UNKNOWN G7 CUP; BIOMET G7 LNR 36MM CAT#010000821 LOT#6475655; UNKNOWN G7 CUP