MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 50MM H; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: ref 110024466 lot 609930 g7 metal liner; ref xl-200156 lot 876400 active articulation bearing; ref 163663 lot 557030 head; ref 163663 lot 624200 modular head 28mm +3 neck; ref 110010269 lot 6831221 g7 shell; ref 00625006540 lot j6851911 screw; ref 00625006540 lot j6730167 screw; ref 00625006540 lot j6694869 screw; ref 11-301322 lot 013220 proximal body; ref 11-300921 lot 032370 distal stem; ref 11-302138 lot 420950 trochanteric bolt; ref 11-302109 lot 583360 trochanteric button.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 - 02008, 0001825034 - 2021 - 02009, 0001825034 - 2021 - 02010, 0001825034 - 2021 - 02011, 0001825034 - 2021 - 02012, 0001825034 - 2021 - 02013, 0001825034 - 2021 - 02015, 0001825034 - 2021 - 02016, 0001825034 - 2021 - 02017, 0001825034 - 2021 - 02018, 0001825034 - 2021 - 02020, 0001825034 - 2021 - 02023.
Event or Problem Description
It was reported that initial unknown right total hip arthroplasty placed approximately 22 years ago.The patient was revised due to poly wear and acetabular osteolysis.After the revision, the patient experienced issues with healing at the incision site.An i&d with exchange of the dual mobility components was performed 2 months later due to infection.The patient continued to experience elevated labs and drainage concerns.The patient was again revised within the month for deep infection with gross purulence in the joint.All components were removed and an antibiotic spacer with constrained cup and liner placed without complication.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.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 event information to report at this time.

• Brand Name: G7 DUAL MOBILITY LINER 50MM H
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12149668
• Report Number: 0001825034-2021-02022
• Device Sequence Number: 4723852
• Product Code: LPH
• UDI-Device Identifier: 00880304703544
• UDI-Public: (01)00880304703544(17)270811(10)029180
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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 Model Number: N/A
• Device Catalogue Number: 110024466
• Device Lot Number: 029180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 99