MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 58G; PROSTHESIS, HIP

Catalog Number	010000666
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Pain (1994); Sleep Dysfunction (2517); Ambulation or Postural Difficulties (2544)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 #: 010000859, g7 neutral liner, lot #: 6227064.Multiple mdr reports were filed for this event, please see associated reports: liner: 0001825034-2022-02193.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.
Additional 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 related to the reported event.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 or Problem Description
No additional information on the reported event.

• Brand Name: G7 PPS LTD ACET SHELL 58G
• Common Device Name: 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: 15484922
• Report Number: 0001825034-2022-02194
• Device Sequence Number: 12083782
• Product Code: PBI
• UDI-Device Identifier: 00880304524255
• UDI-Public: (01)00880304524255(17)280206(1006217068
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 010000666
• Device Lot Number: 6217068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Male