MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD -6MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Dementia (1808); Fall (1848); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Reaction (2414); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: m2a 38one piece 38 x 48 porous rd118848 lot # 694600; mallory head press fit femoral11-104107 lot #28536.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01996.Reported event was confirmed by review of medical records, radiographs, and product photographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Photographs of explanted products were provided.Cup was covered with blood and tissue.The head has black debris on the outer surface.A chunk of tissue was removed from the patient.No other evaluations can be made.Medical notes for revision identified the following left hip pain, edema, metallosis.Patient fell while walking with walker.Lost balance, c/o ankle pain when trying to bear weight.Had been c/o hip pain for 2-3 weeks prior.Patient is noted to be frail and has dementia.History obtained by family.Decreased rom.X-ray shows soft tissue density superior lateral and posterior to left hip consistent with hematoma.No evidence of fracture.Hgb 7.7 low d-dimer 5.5 -elevated, possibly related to fall.Prbcs ordered.No complaint for blood loss as mri shows metallosis and no evidence of active bleeding.Patient has a history of anemia therefor this is not a complaint.Hx of groin pain, x-rays thus far have been negative for left hip.Patient has been receiving oxymorphone which may contribute to weakness and confusion as a known side effect of opioids.Also a history of left ankle swelling for 2 weeks.Ultrasound of le negative for dvt.Cobalt level 4.5 ug/l elevated, chromium 16.2 ug/l elevated.Mri shows large complex peri-articular fluid collection concerning for metallosis.Silver-like focus dimensions, considerable edema within the muscle groups which may be related to hematoma or other.Dr.States no emergent surgical indication.Pathology retrieved from left hip: reactive and degenerative changes to tissue including pigment-laden macrophages, foreign body giant cell reaction and focal necrosis.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 patient underwent a revision procedure seventeen years post implantation due to metallosis, elevated ion levels, swelling and pain.Prior to the revision, the patient was reported to have been walking with a walker, lost balance, and fell.Patient is noted to be frail and suffer from dementia.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, b6, b7, e1, g4, h2, h6.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

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Review of medical records identified extensive metallosis and two pseudotumors, left hip.Culture results negative.Ebl 500ml, 1 unit of blood given.300ml of brownish metallic looking material expressed from pseudotumor.Blackish gray material, short external rotators compromised and iliopsoas.The shell well fixed, but was explanted, spike shell press fit, 28mm head and neck placed.No complications were noted.Post-op hypotension & hgb 6.9, transfused 2 units blood.Noted that the patient had significant low hgb history prior to surgery.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 38MM MOD HD -6MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10052868
• MDR Text Key: 193404415
• Report Number: 0001825034-2020-01995
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2020

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: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 11-173660
• Device Lot Number: 760670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 06/22/2020; 07/23/2020
• Supplement Dates FDA Received: 07/20/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 72