MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS, HIP

Catalog Number	010000662
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient was seen in the emergency room approximately 14 months post implantation following a fall due to unknown reasons.The patient was experiencing pain and difficulty with mobility.Imaging diagnosed a contusion and medication was given for pain management.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00720, 0001822565-2024-00915, 0001822565-2024-00916.D10: cat #: 51-101050 / tprlc 133 fp type1 pps ho 5.0 / lot #: 3799117.Cat #: 30103204 / g7 vit e neutral lnr 32mm d / lot #: 64922381.Cat #: 00625006525 / bone scr 6.5x25 self-tap / lot #: j7053823.Cat #: 650-1162 / delta cer fem hd 32/0mm t1 / lot #: 3084053.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Clinical code to be removed: 1848 - fall.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: acute exacerbation of hip pain after a fall 2 days prior, pain is worsening and radiates.Ct performed due to poor mobility despite negative xrays-also negative, no evidence of loosening or fracture.Resolved with elevation and icing.The complaint is confirmed based on an evaluation of the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.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.

• Brand Name: G7 PPS LTD ACET SHELL 50D
• 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: 18934874
• Report Number: 0001825034-2024-00719
• Device Sequence Number: 7027433
• Product Code: PBI
• UDI-Device Identifier: 00880304524217
• UDI-Public: (01)00880304524217(17)310722(10)7067118
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 010000662
• Device Lot Number: 7067118
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White