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

Model Number N/A

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

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #139252, magnum taper adapter, lot #327230; item #11-104111, mallory head, lot #893820; item #157448, modular head, lot #143440.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The investigation is in process.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 -2019 -02743, 0001825034 -2019-02744.

Event Description

It was reported patient underwent right hip arthroplasty.Subsequently approximately 9 years post op the patient underwent a revision surgery due to pain.It was discovered during this surgery the patient had a severe infection.No devices were removed.Patient is being treated for the infection for 6 weeks, before another revision surgery is scheduled.Additional information was requested however, none was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.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

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 medical records noting elevated metal ion levels, inflammatory markers quite elevated.There is significant purulent material and pseudotumor that was debrided along with scar tissue.The additional information does not change the results of the previous investigation.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 presented with pain, clunking and grinding, and elevated metal ion levels and discussed with the surgeon about the possibility of getting cultures if there was significant purulent appearing material.The patient went in for surgery approximately 9 years post implantation where purulent appearing fluid was encountered, pseudotumor in the trochanteric bursa was debrided and the metal head was noted to be cold welded to the stem.The head component was unable to be removed, so the surgeon irrigated and soaked the hip in betadine, reduced and closed in layers.The patient then returned to the operating room approximately 2 months later.During the surgery, the head component was removed with significant effort.The cup was retroverted and verticle and needed to be medialized to obtain a good fit.Surrounding osteolysis was noted and significant posterior capsule was lost due to debridement.There was also scarring of the sciatic nerve that was debrided as well.Attempts have been made, however additional information is unavailable at this time.

• Brand Name: M2A-MAGNUM PF CUP
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8734344
• MDR Text Key: 149188440
• Report Number: 0001825034-2019-02746
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 831540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2019
• 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 Weight: 88