MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E NEUTRAL LNR 36MM H; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat# 010000668, lot# r7313004a, g7 pps ltd acet shell 62h; cat# 650-0661, lot# 3128008, delta ceramic fem hd 36/0mm; cat# 51-103150, lot# 7198025, tprlc 133 t1 pps so 15x150mm.G2: foreign: netherlands the customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that initial right total hip arthroplasty was performed.The patient underwent repositioning with anesthesia due to dislocation approximately three (3) weeks later.The patient dislocated for a second time due to unknown reasons requiring repositioning approximately two (2) weeks later.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.Subsequently, the patient dislocated approximately 3 weeks later and then again approximately 2 weeks after that (this complaint).Both times the hip was reduced under closed reduction.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 or Problem Description
No further information at the time of this report.

• Brand Name: G7 VIT E NEUTRAL LNR 36MM H
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16682955
• Report Number: 0001822565-2023-00928
• Device Sequence Number: 20635460
• Product Code: LPH
• UDI-Device Identifier: 00889024519930
• UDI-Public: (01)00889024519930(17)270411(10)65454505
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 30103608
• Device Lot Number: 65454505
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 123 KG