MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHETIC, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that the liner could not assemble the cup.The surgery was completed using a bigger cup and corresponding liner.There was a 31 minute delay.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).G2: foreign: china.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00738.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.Device in process to return.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected visual examination of the provided pictures identified the shell has minor scuffing.No additional details can be seen.Unable to confirm complaint.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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

There is no update to the prior event description provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d9; g3; h2; h3.Visual examination of the returned product identified the locking feature of the shell has a piece of debris lodged inside.The liner shows damage to the locking feature.It is unknown if the debris was present during the assembly attempts or during removal of the shell.Complaint confirmed based on evaluation of returned product.A definitive root cause cannot be determined.The returned shell has debris present in the inner radius locking groove which would have caused or contribute to the reported event.Per the g7 acetabular system surgical technique (0190.1-ous-en-rev0516) page 24 - polyethylene liner insertion "ensure the interior of the shell is dry and free of debris and overhanging soft tissue is removed." not cleaning the shell prior to insertion attempts would be considered off-label usage, however, it could not be confirmed when the debris was generated as the shell was explanted after attempting to seat the liner.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 additional event information to report at this time.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16672677
• MDR Text Key: 312757443
• Report Number: 0001825034-2023-00734
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(17)321018(10)7356943
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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: 010000663
• Device Lot Number: 7356943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 010000857 G7 NEUTRAL E1 LINER 36MM E LOT: 7365451.
• Patient Sex: Prefer Not To Disclose