MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY NEUTRAL 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).12-115121-cer bioloxd mod hd 36mm std-2986078 51-103100-tprlc 133 t1 pps so 10x140mm-3702922 010000665-g7 pps ltd acet shell 56f-6478894.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial hip arthroplasty.During the procedure, insertion of the liner into the shell was attempted three times, but was unable to seat.A neutral f liner and poly was opened and secured on first attempt.It was unsure why the 10 f liner would not remain fixed in place.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.Complaint sample was evaluated and the reported event could not be confirmed.Inspection of the returned device revealed 2 scrapes on the outer radius of the liner.The scrapes are located near to a nick in the barb that was also observed.No other damage was found on the outer radius away from this location.No scallop damage or deformation was observed.The rim has been scratched.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot 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.

Event Description

No additional information on reported event.

• Brand Name: G7 LONGEVITY NEUTRAL 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9888578
• MDR Text Key: 185561743
• Report Number: 0001825034-2020-01317
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024518759
• UDI-Public: (01)00889024518759
• Combination Product (y/n): N
• PMA/PMN Number: K190660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2023
• Device Model Number: N/A
• Device Catalogue Number: 20103606
• Device Lot Number: 64396671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 75 YR