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

Model Number N/A

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

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/23/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a left hip revision procedure approximately 8 years post implantation.No additional information is available at the time of this report.

Manufacturer Narrative

(b)(4).Pma/510(k) number is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 00154.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.Device location is unknown.

Event Description

There is no update to the original complaint description provided.

Manufacturer Narrative

Supplemental report provided as the item unknown m/l taper stem previously reported under mfr#: 0001822565-2023-00153 has now been identified.Please see the below updates d1: brand name is femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 standard offset.D4: catalog number.D10: medical product: item number: 00801803202, item name: femoral head sterile product.Do not resterilize 12/14 taper.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: h6: proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided medical records were not provided.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

There is no update to the previous complaint description provided.

Event Description

It was reported that the patient underwent a revision procedure approximately 10 years and 10 months post implantation due to pain, elevated metal ion levels, and metal related pathology.During the procedure a pseudocapsule with thickening, wear, corrosion, bone loss, and bone necrosis were found.The locking ring was also exchanged as it was noted to be unmovable.There were no known complications and no further details are available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: d1: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 standard offset.D4: expiration date and lot number.D6b: device remains implanted.H6: health effect - impact code, health effect - clinical code, device code.

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 the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.Subsequently, a revision occurred due to pain and elevated metal ions.During the revision, a pseudocapsule was identified, as well as darkening and discoloration of the trunnion.The locking ring was stuck and could not move.The liner was damaged to be removed and a new locking ring was placed.Discoloration and roughening was found within the acetabulum, as well as necrotic bone around the trochanteric region.The head, liner, and locking ring were explanted and replaced 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 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: 16194717
• MDR Text Key: 307583410
• Report Number: 0001822565-2023-00153
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/21/2023

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00771101100
• Device Lot Number: 62053429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 01/18/2023; 01/20/2023; 06/22/2023; 09/19/2023
• Supplement Dates FDA Received: 01/19/2023; 01/20/2023; 07/03/2023; 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2012
• 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 NARRATIVE.; UNK VERSYS FEMORAL HEAD.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female