MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 48 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Tissue Damage (2104)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00625006535-bone scr 6.5x35 self-tap-61238593, 00625006525-bone scr 6.5x25 self-tap-61265367, 00631004832-liner 10 degree elevated rim 32 mm i.D.For use with 48 mm o.D.Shell- 61276771, 00877503202- biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14- 2764111.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00060, 0001822565 - 2021 - 00061.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a left hip revision approximately 10 years post implantation due to aseptic loosening of the acetabular shell.During the procedure, upon entering the deep tissue, patient did have mild damage of the abductor muscle; therefore, active articulation bearing placed and it band tenodesis performed.Acetabular component was grossly loose and easily removed; 2 screws were broken through the cup but also easily removed.Appears screws pulled through the shell holes but not actually fractured.The biolox head, initial liner, and initial shell replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via medical records reviewed by a healthcare professional.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.A definitive root cause cannot be determined.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: SHELL POROUS WITH CLUSTER HOLES 48 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11123500
• MDR Text Key: 225280595
• Report Number: 0001822565-2021-00032
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00620004822
• Device Lot Number: 61237814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention