MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-T UNIV 2-HOLE SHL SZ 41/56; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Reaction (2414); Metal Related Pathology (4530)

Event Date 07/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Concomitant medical products: item number: unknown, item name: unknown head, lot #: unknown; item number: unknown, item name: unknown stem, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -01996.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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

It was reported patient was revised due to allegations of pain and metallosis.Attempts have been made and no additional information is available.

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 no deviations or anomalies during manufacturing.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: cat#11-103206 taperloc por lat fmrl 12.5x145 lot#656670.Cat#103532 ti low profile screw 6.5x25mm 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 -2021 -01725.0001825034-2019-01996.0001825034-2019-01997.

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.

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/56
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8575488
• MDR Text Key: 143889992
• Report Number: 0001825034-2019-01997
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2012
• Device Model Number: N/A
• Device Catalogue Number: 15-103686
• Device Lot Number: 085670
• 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
• Patient Outcome(s): Hospitalization; Required Intervention