MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL LINER; PROSTHESIS HIP

Catalog Number 010000857

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 07/08/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: taperloc stem, # item 51-108060, lot 2479105; cer bioloxd option head, # item 650-1057, lot 773770; cer option type 1 taper sleeve, # item 650-1065, lot 683160; g7 acetabular shell, # item 010000663, lot 2804310.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06147, 0001825034-2018-06153 and 0001825034-2018-06154.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

It was reported that the estimated blood loss was 1700 ml during revision due to periprosthetic femoral fracture.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes provided.Revision op note shows estimated blood loss 1700ml.The patient was revised due to increased pain, leg length inequality, chronic periprosthetic fracture with a grossly loose stem.Cerclage cables placed to reduce the lesser trochanteric chronic fracture.Cup and liner left intact.Femoral head/neck and stem replaced.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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 NEUTRAL LINER
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7754108
• MDR Text Key: 116214334
• Report Number: 0001825034-2018-06149
• 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
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 010000857
• Device Lot Number: 2921390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 122