MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ZIMMER M/L TAPER STEM; PROSTHETIC, HIP

Model Number N/A

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Proposed component code: mechanical (g04)- stem.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 00554.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A timeline was created based off the information provided by legal, which states the initial right tha occurred on (b)(6), 2011, and a revision on (b)(6), 2022 due to unknown reasons, where the head and stem were removed.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.H3 other text : device location is unknown.

Event Description

It was reported pt underwent a revision procedure approximately 11 years post-implantation due to unknown reasons.The head and the stem were both exchanged.There is no additional information available at the time of this report.

Event Description

It was reported pt underwent a revision procedure approximately 11 years post-implantation due to development of metal related pathology with revision of shell, head/liner, stem was retained.During the revision it was noted that the capsule was thick, noted pseudotumor with removal, cup removed central bone loss noted, reamed to 55 with 56 shell press fit & screws placed, dual mobility liner impacted, with 46mm dual mobility head and 28+7 head.There were no complications.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1 b1 b4 d1: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 standard offset d4: catalog and lot numbers.D10: 00801803602 femoral head sterile product do not resterilize lot: 61824325 00620205022 shell porous with cluster holes 50 mm 61798428 00625006535 bone scr 6.5x35 self-tap lot number 61760635 corrected: b5 d6b: device remains implanted d2: device product code.Multiple reports were filed for this event, please see associated reports: 0002648920 - 2023 - 00122, 0001822565 - 2023 - 01628, 0002648920 - 2023 - 00123.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 proposed component code: mechanical (g04)- stem.Review of complaint history identified no additional complaints for the stem.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a revision occurred due to metal related pathology.A pseudotumor was removed.When the cup was removed, bone loss was noted.All components but the stem were explanted and replaced with a mix of zb and competitor products with no complications noted.Root cause 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.

• Brand Name: UNK ZIMMER M/L TAPER STEM
• Type of Device: PROSTHETIC, HIP
• 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: 16461154
• MDR Text Key: 310442513
• Report Number: 0001822565-2023-00552
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2023

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 Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 65771100700
• Device Lot Number: 61679277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 05/23/2023; 11/09/2023
• Supplement Dates FDA Received: 06/16/2023; 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.; UNK ZIMMER VERSYS FEMORAL HEAD.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female