MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 50ODX44ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Blood Loss (2597)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: act artic e1 hip brg 28x44mm, pn ep-200150, ln 630420, cer bioloxd option hd 28mm, pn 650-1055, ln 179850, cer option type 1 tpr sleve -6, pn 650-1064, ln 2887399, taperloc por lat fmrl 9x137, pn 11-103203, ln unknown.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2019-03162.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The patient was revised for a pseudotumor, blood loss, hematoma, osteolysis, tissue damage was noted with positive frozen sections, and pain.Implant wear was also noted due to disassociation of the active articulation system.During the procedure, it was further noted patient experienced an estimated blood loss of 1200ml and received a transfusion.The acetabular shell, head, and liner were replaced, and the patient was placed on prolonged iv antibiotics.

Event Description

The patient was revised for a pseudotumor, blood loss, hematoma, osteolysis, tissue damage was noted with positive frozen sections, and pain.Implant wear and dislocation was also noted due to disassociation of the active articulation system.During the procedure, it was further noted patient experienced an estimated blood loss of 1200ml and received a transfusion.The acetabular shell, head, and liner were replaced, and the patient was placed on prolonged iv antibiotics.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Reported event was confirmed by review of medical records.Medical records indicate patient experienced multiple dislocations and disassociation.Patient revised.Medical records indicated during revision: pseudotumor, hematoma, osteolysis, and tissue damage was noted with positive frozen sections.Implant wear was also noted due disassociation of the active articulation system.Patient was placed on prolonged iv antibiotics.Device history record (dhr) 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-MAGNUM PF CUP 50ODX44ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8825753
• MDR Text Key: 152166136
• Report Number: 0001825034-2019-03161
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: US157850
• Device Lot Number: 296330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2019
• 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