MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Respiratory Failure (2484)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00620005622 shell porous with cluster holes 56 mm o.D.62954811.00625006550 bone screw self-tapping 6.5 mm dia.50 mm length 63003489.650-0662 delta ceramic fem hd 36/+3mm 3053017.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
It was reported that a patient underwent an initial left total hip arthroplasty.One year post implantation, the head and stem were revised due to loosening of the femoral component with failure to osseointegrate.The patient was revised for a second time, five years post implantation due to fracture of the revision stem with complicated extraction via extended trochanteric osteotomy.After the second revision, the patient experienced recurrent dislocations requiring closed reduction under anesthesia.A third revision was planned but delayed due to difficulty extubating the patient and the concurrent onset bilateral pulmonary embolisms.After the patient¿s pulmonary function and anticoagulation measures were stabilized, the revision occurred during which, multiple hematomas were evacuated from the joint, and posterior instability was confirmed on exam.Upon replacing the acetabular shell, anteversion was increased by 15 degrees.A new constrained head and liner were placed within the shell, and the revision stem was retained.Postoperatively, the patient demonstrated slow but steady progress with intensive physical therapy.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event for the liner.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.The patient has undergone two revisions and due to loosening of the stem and fracture of the revision stem.The patient underwent a third revision due to dislocation, instability, and pain.Leading up to the revision, the patient experienced a hematoma that was resolved prior to surgery.During surgery, the shell was well fixed but removed to improve stability.The shell, liner, head, and screw were explanted and replaced with zb products.A definitive root cause cannot be determined for the instability, pain, and dislocations.No problem was found with all devices in relation to the hematoma after review by a hcp.No problem was found with the screw upon receipt of the medical records.This 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL
• Common Device Name: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18825307
• Report Number: 0001822565-2024-00726
• Device Sequence Number: 20802987
• Product Code: JWH
• UDI-Device Identifier: 00889024123816
• UDI-Public: (01)00889024123816(17)220630(10)63687030
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K972774
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00630505636
• Device Lot Number: 63687030
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Race: White