MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 PPS LTD ACET SHELL 52E; PROSTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly.Requested but not returned by hospital.

Event Description

During a total hip arthroplasty, it was noticed that the surgeon implanted the cup with too much retroversion.The cup was removed and repositioned.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.(b)(4).

Event Description

It was reported that during a total hip arthroplasty, the surgeon implanted the cup with too much retroversion, due to a lack on experience.The cup was removed and repositioned.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical product - g7 acetabular liner catalog#: 010000857 lot#: 3776776, femoral stem.Catalog#: 192110 lot#: 229170, g7 screw catalog#: 010000998 lot#: 3559051, delta ceramic head.Catalog#: 650-1057 lot#: 999700, ceramic taper sleeve catalog#: 650-1067 lot#: 865810.Reported event was unable to be confirmed due to limited information received from the customer.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 contribute to monitor for trends.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5906076
• MDR Text Key: 53077811
• Report Number: 0001825034-2016-03301
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000663
• Device Lot Number: 3722697
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• 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
• Patient Outcome(s): Required Intervention