MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY HIGH WALL 40MM F; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Unstable (1667); Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Subluxation (4525); Metal Related Pathology (4530)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: item number 010000664 item name g7 pps ltd acet shell 54f lot # 6803742.Item number 00625006530 item name bone screw self-tapping6.5 mm dia.30 mm length lot# j6813932.Item number 00625006525 item name bone screw self-tapping6.5 mm dia.25 mm length lot # j6817641.Item number 00625006520 item name bone screw self-tapping6.5 mm dia.20 mm length lot # 64558809.Item number 650-1058 item name cer bioloxd option hd40mm 0 lot # 3032856.Item number 650-1064 item name cer option type 1 tprsleve -6 pe 1 lot # 3031442.Item number 51-108080 item name tprlc 133 mp t1 pps so8x101mm lot # 6685818.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Medical records were provided and reviewed by a health care professional.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.Previously incorrectly reported under mfr: 0001825034 - 2021 - 00087.
Event or Problem Description
T was reported the patient stated she underwent a tha.Subsequently, patient underwent a revision 3 months later.Surgeon reported that liner had dissociated and there was direct ceramic head contact with shell, leading to metallosis, metallic debris, implant wear to shell, and pseudotumor.No further event information available at the time of this report.

• Brand Name: G7 LONGEVITY HIGH WALL 40MM F
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11862342
• Report Number: 0001822565-2021-01406
• Device Sequence Number: 1099723
• Product Code: LPH
• UDI-Device Identifier: 00889024519381
• UDI-Public: (01)00889024519381(17)241031(10)64577165
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 20124006
• Device Lot Number: 64577165
• 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: 12/31/2020
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Weight: 79