MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD+9MM NK NO SKRT; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Reaction (2414); No Information (3190)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item# unk, hips-unknown-stems-unk, lot # unk.Item# unk, hips-unknown-cups-unk, lot # unk.Multiple reports were filed for this event, please see associated reports: 0001825034-2018-01644, 0001825034-2018-01647.

Event Description

It was reported that a patient is being considered for a revision due to an unknown reason.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This follow up report is being submitted to report additional information concomitant medical products- unknown cup; unknown liner; unknown stem.Reported event was confirmed due to medical records received.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.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

It was reported that a patient underwent primary right hip arthroplasty due to unknown reasons.The patient then underwent a revision surgery due to metallosis, necrotic tissue, and corrosion of the taper.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

(b)(4).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 that the patient's right hip was revised approx 15 years post implantation due to pain, metallosis, elevated metal ions, corrosion, necrosis.Metallosis stained tissue and necrotic tissue around hip joint debrided were seen.Some corrosion at tip of the taper of the femoral head were noted.Head was revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

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.Reported event was confirmed by review of op notes provided.Primary op notes confirms the patient underwent primary right hip arthroplasty with out any complications.Revision op notes indicated the presence of fluid layer and no purulence at all.The hip area has lot of gray-yellow fluid and cultures of this fluid were negative for infection but it has some inflammatory reaction related to metallosis.There is also presence of some metallosis stained and necrotic tissue.There was some corrosion at the tip of the taper.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: M2A 38MM MOD HD+9MM NK NO SKRT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7310623
• MDR Text Key: 101417201
• Report Number: 0001825034-2018-01646
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 11-173665
• Device Lot Number: 547500
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• 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
• Patient Age: 66 YR