MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000935 ¿ g7 hi-wall liner ¿ 6579225.010000927 ¿ g7 hi-wall liner- 6351780.Report source: (b)(6).The product is in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01602.0001825034 - 2020 - 01603.

Event Description

It was reported that during a hip revision surgery, a cup was implanted without complication.Two different liners were attempted to be implanted without success.A new liner and cup combo were used to complete the surgery with approximately 50 minutes of delay in the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event is unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 52MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9947861
• MDR Text Key: 187385596
• Report Number: 0001825034-2020-01604
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304544192
• UDI-Public: (01)00880304544192
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

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: 110010244
• Device Lot Number: 6669360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 05/13/2020
• 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: 54 YR