MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 58 MM O.D.; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Ossification (1428); Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 00801803202- femoral head sterile product do not resterilize 12/14 taper- 61452278; 00784802200- modular neck b 12/14 neck taper use with +0 heads only- 61450114; 00631005832- liner 10 degree elevated rim 32 mm i.D.For use with 58 mm o.D.Shell- 61405420; 00771301300- modular femoral stem press-fit plasma sprayed cementless size 13.5- 61403156.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2021 - 00027, 0001822565 - 2021 - 00028.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.Product location unknown.

Event Description

It was reported patient underwent a right hip revision approximately 10 years post implantation due to pain, stiffness, elevated metal ions, and trunnionosis.During the revision, significant heterotopic ossification was removed.The head and liner were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

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.Review of the device history record for the shell identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history for the shell found no additional related issues for these items and the reported part and lot combinations.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.

Event Description

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

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 58 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11307828
• MDR Text Key: 231166914
• Report Number: 0001822565-2021-00321
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00620005822
• Device Lot Number: 61368472
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention