MAUDE Adverse Event Report: G7 NEUTRAL ARCOMXL LNR 36MM E; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Sleep Dysfunction (2517); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: cat#010000663 g7 pps ltd acet shell 52e lot#6142979; cat#51-104100 tprlc 133 t1 pps ho 10x140mm lot#3195404; unk biolox head.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies 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.
Event or Problem Description
It was reported patient is experiencing pain, difficulty walking and difficulty sleeping 3 years post implantation.Patient stated she thinks she may be allergic to the titanium and is having testing done.Attempts to obtain additional information have been made; however, no more is available at this time.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM E
• Common Device Name: PROSTHESIS, HIP
• MDR Report Key: 12751398
• Report Number: 0001825034-2021-03045
• Device Sequence Number: 18458443
• Product Code: LPH
• UDI-Device Identifier: 00880304524972
• UDI-Public: (01)00880304524972(17)221114(10)6159313
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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 Expiration Date: 11/14/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000740
• Device Lot Number: 6159313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 79