MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 48MM C; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00771100610 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 6 standard offset reduced neck length 62528353 00877503202 biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 3073984 30103203 g7 vit e neutral lnr 32mm c 65233890.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.
Event or Problem Description
As reported by legal, the patient underwent an initial left total hip arthroplasty.Subsequently, post-operative imaging demonstrated a size mismatch between the femoral head and acetabular liner implanted.As a result, revision surgery occurred where the size 36mm head was exchanged for a size 32mm head.The patient reported bilateral hip pain with left hip being greater than the right and not being able to walk up or down stairs.Patient was prescribed aqua therapy but has reported she has yet to start due to financial reasons.The patient underwent a procedure for implantation of a lumbar spinal cord stimulator.During a follow-up appointment, the patient reports 100% pain relief.No further allegations have been reported.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;g3;h2;h3;h6.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left total hip arthroscopy was performed approximately three years ago.Two days later, a revision occurred to correct the mismatch of the head size for the liner implanted.Approximately six months later, the patient reported bilateral hip pain and difficulties ambulating and a slight left leg shortening was identified.The patient was then reported to have a spinal cord stimulator implanted with 100% pain relief reported.No revision occurred for the hip implants.It is unknown if the leg lengths are still different and if that contributed to the pain.A definitive root cause cannot be determined.It was reported the patient was implanted with a spinal stimulator that relieved 100% of the pain; however, the patient still had limb length discrepancies and it is unknown if those contributed to the reported pain.The complaint was confirmed based on the provided medical records.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 OSSEOTI 3 HOLE SHELL 48MM C
• Common Device Name: PROSTHESIS, HIPS
• 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: 18907219
• Report Number: 0001825034-2024-00728
• Device Sequence Number: 17744963
• Product Code: LPH
• UDI-Device Identifier: 00887868355868
• UDI-Public: (01)00887868355868(17)310715(10)70695585
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 07/16/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110010242
• Device Lot Number: 7069585
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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
• 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 Sex: Female
• Patient Weight: 86 KG
• Patient Race: White