MAUDE Adverse Event Report: . M2A 38MMX58MM CUP; PROSTHESIS HIP

Catalog Number RD118858

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Migration (4003)

Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.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: (b)(4).

Event Description

It was reported that patient underwent a revision procedure due to pseudotumor and elevated ion levels.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.The following sections were updated/corrected.

Event Description

It was further reported through patient's medical records that the patient underwent a revision surgery due to pseudotumor, elevated metal ion levels, discomfort, clicking noise, and metallosis.Surgeon noted during the revision procedure that there was large amounts of fibrous tissue around the neck and ball region.Further, the patient had scar tissue around the periphery of the acetabular component.Finally, the acetabulum was somewhat retroverted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Visual examination of the provided pictures identified scaring, scratching, and typical wear identified on an implanted and explanted device review of the available records identified the following: (summarized by hcp) revision due to pseudotumor, elevated metal ions, presented with initial 17 years prior, done well until recently with presentation of clicking noise, discomfort in the groin and buttock region of right hip.Darkly black stained tissue, about 2mm thickening and lined entire capsule of hip which was quite enlarged, extended over trochanteric area laterally.Large amount of fibrous tissue noted around neck and ball region.No evidence of trunnionosis.Scar tissue noted around periphery of the acetabular component, acetabulum was somewhat retroverted and removed.30 cc of cancellous bonechips with 10cc of bone morphogenic protein used in the medial wall area.Upon implantation of g7 multi-hole cup, 3 screws were placed along with the dual mobility liner, and +3 permanent head with a +3 titanium sleeve in which rom and stability were excellent.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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 38MMX58MM CUP
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11230576
• MDR Text Key: 228687719
• Report Number: 0001825034-2021-00151
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

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: 12/30/2013
• Device Catalogue Number: RD118858
• Device Lot Number: 457440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/11/2021; 05/10/2021
• Supplement Dates FDA Received: 03/24/2021; 05/19/2021
• 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