MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).20113204 65038188 g7 longevity 10deg lnr 32mm d 11-363660 937920 36mm cocr mod hd -6mm.Unknown stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.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: 0001825034-2022 -00238.

Event Description

It was reported the patient underwent initial hip arthroplasty.Subsequently, the patient was revised due to pain, acetabular component loosening, and soft tissue impingement caused by incompatible head and liner component implantation.The cup.Liner and head were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported the patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 7 months post implantation due to pain, acetabular component loosening, and soft tissue impingement caused by incompatible head and liner component implantation.The cup.Liner and head were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs received.Visual examination of the provided pictures identified a size 36mm head was used with a size 32mm liner and a g7 cup.No other information can be obtained from the image.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to the mismatched head and liner combination used, a 32mm liner is not designed to use a 36mm head as it would not seat in the liner appropriately.A definitive root cause cannot be determined for the loose cup.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 50D
• Type of Device: PROSTHESIS, HIP
• 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: 13423895
• MDR Text Key: 285151936
• Report Number: 0001825034-2022-00239
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304524217
• UDI-Public: (01)00880304524217(17)301201(10)6911125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000662
• Device Lot Number: 6911125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 02/02/2022; 03/25/2022
• Supplement Dates FDA Received: 02/03/2022; 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization