MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the product is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient presented with persistant pain approximately 1 year post implantation.Patient underwent right hip arthroscopy with iliopsoas tendon release due to chronic iliopsoas inflammation.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.Concomitant medical products : 010000849 - g7 neutral e1 liner 32mm e ¿ 3334821, 51-145140 - tprlc xr mp t1 pps 14x113mm ¿ 3011808, 650-1056 - cer bioloxd option hd 32mm ¿ 654120, 650-1066 - cer opt type 1 tpr sleve 0mm ¿ 696900.Reported event was confirmed by review of provided operative notes.Operative notes from the arthroscopy shows that the patient had tendinopathy requiring the release of the iliopsoas tendon.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: G7 ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7758723
• MDR Text Key: 116297020
• Report Number: 0001825034-2018-06505
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• 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: 010000663
• Device Lot Number: 3434528
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 75