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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Respiratory Failure (2484)

Event Date 08/26/2021

Event Type  Injury  

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 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.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL
• Type of Device: 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
• MDR Text Key: 336744100
• Report Number: 0001822565-2024-00726
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972774
• 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: 03/01/2024

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
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/04/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Race: White