MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXCD ABT SPRING LOADED IMPACTR; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Source: (b)(6).Concomitant medical devices: catalog number: 110010249, lot number: r3594169a, brand name: g7 osseoti 4 hole shell 62mm h.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04293 customer has indicated that the product is in process of being returned to zimmer biomet for investigation.

Event Description

It was reported that during an initial hip arthroplasty, the exceed inserter handle was stuck inside the g7 shell and could not be detached.This led the surgeon to explant the g7 shell back out the patient after it had been implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.The root cause of the reported issue is attributed to off label use of the g7 implants and exceed instruments."it was initially reported that an incompatible inserter was used in off-label fashion with a g7 cup.Through investigation, it was confirmed that the exceed inserter and g7 cup are indeed dimensionally non-compatible and functionally unable to be used together.Therefore, there was no malfunction of same/similar products that have previously caused or contributed to a serious adverse event, in this instance, and the root cause of the dysfunction was off-label use.Additionally, there was no patient harm or serious adverse event in this event.There are no reports of previous off-label use in this manner causing or contributing to a serious injury.Internal corrective and preventive actions have been initiated to investigate the off-label use of the device." event is no longer considered reportable, and initial report should be voided.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

"it was initially reported that an incompatible inserter was used in off-label fashion with a g7 cup.Through investigation, it was confirmed that the exceed inserter and g7 cup are indeed dimensionally non-compatible and functionally unable to be used together.Therefore, there was no malfunction of same/similar products that have previously caused or contributed to a serious adverse event, in this instance, and the root cause of the dysfunction was off-label use.Additionally, there was no patient harm or serious adverse event in this event.There are no reports of previous off-label use in this manner causing or contributing to a serious injury.Internal corrective and preventive actions have been initiated to investigate the off-label use of the device." event is no longer considered reportable, and initial report should be voided.

• Brand Name: EXCD ABT SPRING LOADED IMPACTR
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10979765
• MDR Text Key: 221273849
• Report Number: 0001825034-2020-04296
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 31-601587
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1