MAUDE Adverse Event Report: ZIMMER BIOMET, INC. R/C II CONSTRAINED LINER SZ 26; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Osteolysis (2377)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown stem, lot #: unknown.Item #: unknown, unknown cup, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2021-00505.

Event Description

It was reported that patient underwent total hip arthroplasty on an unknown date.The patient underwent a revision due dislocation.The liner and head components were removed and replaced.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4) reported event was confirmed by review of radiographs.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.Xray review notes a left total hip arthroplasty with asymmetric superior position of the femoral head within the acetabular cup suggesting polyethylene wear with partial but not complete dislocation.Possible fracture involving the left medial acetabulum.Osteopenia significantly limits evaluation.The acetabular cup appears to be vertical in position.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: R/C II CONSTRAINED LINER SZ 26
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11347801
• MDR Text Key: 232517736
• Report Number: 0001825034-2021-00501
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: K021728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-107006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2021
• 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