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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 06/07/2022

Event Type  Injury  

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 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.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 48MM C
• Type of Device: 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
• MDR Text Key: 337700385
• Report Number: 0001825034-2024-00728
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White