MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E 10DEG LNR 36MM G; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported liner would not seat cup.The cup was dried; screws were checked to ensure they were down the entire way.Eventually a new 10-degree liner was offered and it immediately seated correctly.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products:¿ 110010248- g7 osseoti 4 hole shell 60mm g- 65300689; 192414- echo por fmrl red nc 14x150mm- 379810; 650-0663- delta ceramic fem hd 36/+6mm- 3076984; 010000997- g7 screw 6.5mm x 20mm- 7070374; 010000998- g7 screw 6.5mm x 25mm- 7134899.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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 additional information on the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified nicks and gouges to the inner and outer spherical surfaces, face, anti-rotation scallops, and locking feature from attempted implantation.No other damage was noted.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 additional information on the reported event.

• Brand Name: G7 VIT E 10DEG LNR 36MM G
• 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: 15225545
• Report Number: 0001822565-2022-02370
• Device Sequence Number: 12256496
• Product Code: LPH
• UDI-Device Identifier: 00889024520219
• UDI-Public: (01)00889024520219(17)250131(10)64643459
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 30113607
• Device Lot Number: 64643459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/24/2022
• Supplement Date Received by Manufacturer: 09/02/2022; 10/13/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/02/2022; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• 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: NI
• Patient Sequence Number: 1
• Patient Sex: Male