MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-TAPER LINER SZ 41/32; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

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

Event Date 07/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Cat#11-103206, taperloc por lat fmrl 12.5x145 and lot#656670.Cat#103532, ti low profile screw 6.5x25mm and lot#613380.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: 0001825034-2019-01996 and 0001825034-2019-01997.

Event Description

It was reported a patient underwent initial left total hip arthroplasty approximately 19 years ago.Subsequently, the patient was revised approximately 3 years ago due to pain, elevated metal ions, and metallosis.During the revision, corrosion was found at the cup and liner.The stem was well-fixed and left intact.All other components 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.The following sections were updated/corrected updated: d4, h2, h4, h6 medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: stress dose steroids and arixtra given due to history of hit (heparin-induced thrombocytopenia) presented with pain, elevated crp (30, normal <8), labs negative for infection, cobalt and chrome elevated with cobalt 4x the chromium, preoperatively diagnosed with altr creamy gray fluid encountered, no corrosion was seen at the head/neck junction stem stable and left intact 'the entire superior acetabulum and posterior wall was gone.The liner for the metal cup was removed and a significant amount of corrosion was seen at the liner/cup.' surgeon notes that metallosis was falsely elevating wbc count and does not feel this was an infection but wanted to proceed with caution and treat with iv antibiotics for 6-8 weeks prophylactically stem remained intact, head and sleeve replaced with biomet, acetabular components replaced with competitive components, no complications a review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have attributed to the event 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: M2A-TAPER LINER SZ 41/32
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11950692
• MDR Text Key: 255627661
• Report Number: 0001825034-2021-01725
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K993438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2012
• Device Model Number: N/A
• Device Catalogue Number: 15-105004
• Device Lot Number: 521100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• 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