MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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 - 2020 - 04129.

Event Description

It was reported patient underwent an initial hip surgery.During the procedure, surgeon had difficulty seating the liner.Multiple attempts to seat the liner were made and after seating the liner, surgeon checked that it was in place using forceps.Two days post surgery, it was discovered that the head developed position bias and it was suspected that the liner had slipped.Three days post implantation, the liner was removed and site was rinsed thoroughly before repositioning the liner.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by examination of photographs.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Visual examination of the provided pictures identified the head is still inside of the liner.No other information could be obtained from the provided pictures related to the event of the liner disassociating from the cup.As mentioned in the description it is unknown if the liner was fully seated as they had initial difficulty seating the liner.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 48C
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10859877
• MDR Text Key: 216833825
• Report Number: 0001825034-2020-04130
• Device Sequence Number: 1
• Product Code: PBI
• 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
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 010000661
• Device Lot Number: 6421223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: (B)(4) G7 LINER 6722571; 010000925 G7 LINER 6722571
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 55