MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM E; PROSTHETIC, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Item number 650-1057 item name cer bioloxd option hd36mm lot # 2957963.Item number 650-1064 item name cer option type 1 tprsleve -6 lot # 2959033.Item number 51-106110 item name tprlc 133 mp type1 pps so11.0 lot # 6473490.Item number 00625006520 item name bone scr 6.5x20 self-tap lot # 64032379.Item number 00625006525 item name bone scr 6.5x25 self-tap lot # 64386886.The device will not be returned for analysis, remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

Event Description

It was reported by the sales rep that their accountant complained to about a bad hip surgery that was done in july of 2019.She complains of extreme pain, and has been trying to get the doctor to help her.The doctor has said the cup liner separated.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.The following sections were updated/corrected updated: g3; h2; h3; h4; h6.  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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 further event information available at the time of this report.

• Brand Name: G7 NEUTRAL E1 LINER 36MM E
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11897576
• MDR Text Key: 259659138
• Report Number: 0001825034-2021-01623
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526426
• UDI-Public: (01)00880304526426(17)240316(10)6505015
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000857
• Device Lot Number: 6505015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 63 YR