MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM G; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Year of birth: (b)(6).Concomitant medical products: 010000706 3786916 g7 bonemaster ltd acet shl 58g, 51-111130 3647752 tprlc 133 fp type1 bm ho 13.0.Report source: foreign country- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02828, 0001825034 - 2021 - 02830.
Event or Problem Description
It was reported patient underwent initial hip arthroplasty on unknown date.Subsequently the patient experienced intermittent, sharp pain below the waist toward right hip joint exacerbated by sitting.The patient was treated with medication.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.No intervention to date for complaint.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.No intervention to date for complaint.The initial report was forwarded in error and should be voided.

• Brand Name: G7 HI-WALL E1 LINER 36MM G
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12610433
• Report Number: 0001825034-2021-02829
• Device Sequence Number: 2533157
• Product Code: PBI
• UDI-Device Identifier: 00880304527126
• UDI-Public: (01)00880304527126(17)210323(10)3761000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 03/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000937
• Device Lot Number: 3761000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 10/27/2021
• 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: Other
• Patient Weight: 82