MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHESIS, HIPS

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: 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.

Event Description

It was reported the surgeon tried to implant the shell into the patient.He achieved good stability with the implant.When we tried to remove the acetabular shell inserter, the inserter appeared to be stuck on.We used mechanical advantage to try to dislodge the shell but it did not work.In the end the shell needed to be removed and a new shell was used.The new shell went in without a challenge which led us to the conclusion that potentially the shell was faulty or simply cross threaded.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

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6   no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.  the root cause of the reported issue is attributed to off-label usage of the device.G7 surgical technique states use of g7 monoblock and modular handle assembly inserters can be used and the technique does not recommend any other instrument.Straight shell inserter was used with incompatible g7 pps ltd acet shell 56f.  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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual inspection of the returned shell found that the square orientation feature to be deformed, 2 locations per side.The inner most thread is dinged with a small amount of debris present within the threads.Root cause does not change from 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 PPS LTD ACET SHELL 56F
• Type of Device: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11348431
• MDR Text Key: 232552775
• Report Number: 0001825034-2021-00537
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524248
• UDI-Public: 00880304524248
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 010000665
• Device Lot Number: 6840368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER CUP INSERTER, CAT#00780401520, LOT#63490653.; ZIMMER CUP INSERTER, CAT#00780401520, LOT#63490653.