MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: catalog number:00801803202 lot number: 61947585 brand name: femoral head; catalog number:00620205022 lot number: 61977279 brand name: tm modular cup; catalog number:00631005032 lot number: 61970773 brand name: acetabular liner.Multiple reports were submitted along with this report 0002648920-2021-00069.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to pain, elevated ion levels, adverse location tissue reaction (altr) and bone loss at the posterior proximal femur approximately 7 years post implantation.During the revision procedure, the surgeon noted corrosion around the trunnion and in the femoral head.The femoral head was removed and replaced.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was revised due to pain and elevated metal ions.Corrosion was found at the neck head junction on the trunnion, with evidence of altr and loss of all cancellous bone in the posterior proximal femur.Additionally, there was thick, dark bloody fluid in the capsule.Good ingrowth was found and attempts to extract the component were unsuccessful so the implant was not removed.The acetabular component was well ingrown and the polyethylene was in good shape without staining or wear.Only the head was replaced, the stem, liner, and shell were left intact.The head was replaced with a new zimmer biomet device.The pathology report for the gross analysis of the head found synovitis, but was negative for acute inflammation and features of alval were not seen.Patient continues to experience ongoing hip pain.Reported event was confirmed by review of medical records provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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: FEMORAL STEM 12/14 NECK TAPER PLASMA
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11604299
• MDR Text Key: 243529654
• Report Number: 0001822565-2021-00903
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024131781
• UDI-Public: (01)00889024131781(17)310122(10)61963088
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00771101000
• Device Lot Number: 61963088
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention