MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM RECAP CUP 48ODX42ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

Patient Problems Abscess (1690); Congenital Defect/Deformity (1782); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 07/27/2021

Event Type  Injury  

Event Description

According to legal allegations, an initial left total hip was performed due to congenital hip dysplasia.Subsequently the patient felt a bump which progressed to increased pain and difficulty walking.The patient underwent a debridement with irrigation and pathology confirmed a neutrophilic abscess with metallosis.Later, the patient underwent the first part of a two-stage revision due to an unknown infection, metallosis, elevated metal ions, and a pseudotumor.During the stage i revision, the head was unable to be removed from the taper, extensive debridement of friable soft tissue and surrounding metallosis was performed, loss of bone around calcar and greater trochanter region, and the acetabulum was found deficient secondary to the patient¿s congenital hip dysplasia.All components, except the stem were removed and an antibiotic spacer was placed.The patient underwent stage ii of the revision.During the surgery the abductor muscles were found to be destroyed, significant scar tissue was found throughout, the acetabulum had to be recreated, and significant bone loss was found.The loose femoral stem was removed and noted to have complete destruction of the proximal femur and proximal trochanter.The surgery was completed without further complications and competitor product was implanted.Attempts have been made and no further information has been provided at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00428 0001825034 - 2023 - 00430 0001825034 - 2023 - 00431 reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues, unable to bear weight, increase in pain, definite infection, cobalt and chromium levels noted, great concern with loss of soft tissue, infected left hip with pseudotumor.Visual examination of the provided pictures identified the head/stem/shell all explanted but no other information can be obtained from the image.Part and lot identification are necessary for review of device history records, only the lot number was received.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.

Manufacturer Narrative

Visual examination of the provided pictures identified the head/stem/shell all explanted but no other information can be obtained from the image.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues bump noticed, unable to bear weight, increase in pain, definite infection.Cobalt and chromium levels noted.Great concern with loss of soft tissue.Infected left hip with pseudotumor.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 information at the time of this report.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.One cup was returned.The shell outside diameter has missing porous along with scuffing and scratches to the inside radius.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues bump noticed, unable to bear weight, increase in pain, definite infection.Cobalt and chromium levels noted.Loss of soft tissue.Infected left hip with pseudotumor.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.

• Brand Name: M2A-MAGNUM RECAP CUP 48ODX42ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16457261
• MDR Text Key: 310405400
• Report Number: 0001825034-2023-00429
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 05019279927593
• UDI-Public: (01)05019279927593(17)150901(10)935738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

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: 09/01/2015
• Device Model Number: N/A
• Device Catalogue Number: 157848
• Device Lot Number: 935738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 06/19/2023; 01/23/2024
• Supplement Dates FDA Received: 06/20/2023; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female