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

Catalog Number 010000859

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat #: 136536320 / j&j delta-head ceramic / lot #: 8759257.Cat #: 157011150 / j&j stem, summit / lot #: hp3561.Cat #: 010000666 /g7 pps ltd acet shell/lot #:6217068.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02194 the device will not be returned for analysis, due to the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Event Description

It was reported that the patient underwent a right total hip arthroplasty.Subsequently, on an unknown date, patient started to experience pain, difficulty walking and trouble sleeping for long periods of time.No plan for revision has been reported to date.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: d4; g3; h2; h3; h4; h6 complaint was confirmed via medical records reviewed by a health care professional.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It is noted that zimmer biomet products were used in conjunction with a competitor device.Zimmer biomet has not confirmed the compatibility of the reported combination of devices, and these would be considered off-label usages.However, it cannot be confirmed that the combination of the johnson and johnson and zimmer biomet products caused or contributed to the reported event.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 the reported event.

• Brand Name: G7 NEUTRAL E1 LINER 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15469639
• MDR Text Key: 300426940
• Report Number: 0001825034-2022-02193
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526440
• UDI-Public: (01)00880304526440(17)230207(10)06227064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2023
• Device Catalogue Number: 010000859
• Device Lot Number: 6227064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male