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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 modular head 38 diameter minus 6 mm 11-173660 lot# 760670; 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 - 01995. 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.
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Brand NameM2A 38MMX48MM CUP
Manufacturer (Section D)
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
MDR Report Key10052601
MDR Text Key193404094
Report Number0001825034-2020-01996
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
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
Date FDA Received05/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2013
Device Model NumberN/A
Device Catalogue NumberRD118848
Device Lot Number694600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/13/2020 Patient Sequence Number: 1