MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM NH COLLARED 12/14 3 R; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Insufficient Information (3190)

Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01710.

Event Description

It was reported that the patient underwent a revision procedure approximately 10 years post implantation due to unknown reasons.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 unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: catalog#: 00801803601 femoral head sterile 12/14 taper lot#: 61220022, catalog#: 00620205422 shell porous with cluster holes 54 mm lot#: 61180463, catalog#: 00630505036 liner standard 3.5 mm offset 36 mm i.D.Lot#: 61245046, catalog#: 00625006515 bone scr 6.5x15 self-tap lot#: 6124639.The following sections were updated/corrected.Updated: a1, a4, b1, b4, b5, b6, b7.D4, d6b, d10, e1, g3, g4, g6, h2, h4, h6, h10.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03018, 0002648920-2021-00363.

Event Description

It was reported that the patient underwent a revision procedure approximately 10 years post implantation due to pain, elevated metal ions, and trunnionosis.During the revision, extensive heterotopic ossification and scar tissue was removed.Wear discoloration was noted on the acetabulum, but it was left in place.Only the head and liner were exchanged without complication.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.Subsequently the patient was revised due to pain and elevated metal ions.During the revision, a large amount of ho was excised from the acetabulum and some wear discoloration was present.Black trunnionosis was present on the femoral head and trunnion of the stem.The head and liner were replaced with no complications.Root cause remains unchanged.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: STEM NH COLLARED 12/14 3 R
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12049962
• MDR Text Key: 258006576
• Report Number: 0001822565-2021-01709
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2022

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: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 7354-02-203
• Device Lot Number: 60610469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 07/15/2021; 09/20/2021; 02/08/2022
• Supplement Dates FDA Received: 07/16/2021; 10/15/2021; 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2007
• 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; UNKNOWN VERSYS FEMORAL HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male