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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Ossification (1428); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Tissue Damage (2104); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03789.0001825034 - 2020 - 03790.0001825034 - 2020 - 03791.

Event Description

It was reported a patient had an initial left tha.Subsequently, the patient was revised approximately 11 years later due to metallosis, pain, ho, elevated metal ion levels, altr, scar tissue, and tissue damage.The head and the taper adapter were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: failed left total hip arthroplasty with metallosis.Intractable left hip pain.Debridement of heterotopic bone.Release contractures.Noted to have elevated cobalt and chromium levels.Acetabular components are noted to be substantially medialized with violation of the medial acetabular wall of the pelvis (this may have been necessary due to her developmental hip dysplasia.It is also noted the revision surgeon opted to retain both the acetabular and femoral components).Mri preoperatively with mar sequencing which demonstrated possibility of altered soft tissue reaction surrounding the joint secondary to metallosis.Significant overgrowth and hypertrophy of the greater trochanteric bursa.Evidence of mild metallosis surrounding the peri-articular soft tissues.Significant scarring throughout the entire soft tissue surrounding the hip with thickening and obliteration of normal tissue planes.Redundant soft tissue within the anterior hip and anterior femur were resected with sharp dissection without disruption of the implants.Good rom with stability.Implants that were removed were sent to palos hospital pathology department for analysis and gram stain with frozen section intraoperatively returned no evidence of acute inflammation a review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

Event Description

No further event information available at the time of this report.

• 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: 10683598
• MDR Text Key: 211468727
• Report Number: 0001825034-2020-03788
• Device Sequence Number: 1
• Product Code: LPH
• 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: 11/24/2020

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: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: US157850
• Device Lot Number: 505000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 11/25/2020
• 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