MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR HD 28MM X -3.5; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Necrosis (1971); Joint Dislocation (2374)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer cat# 01.06010.306 avenir stem lat cemented 6 lot# 3039253 zimmer cat# 00500105200 shell 52 mm o.D.Lot# 64892224.Report source: foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00461.

Event Description

It was reported that patient underwent a left hip arthroplasty.Subsequently, the patient was revised approximately 2.5 weeks later due to dislocation.It is believed that the original femoral component was cemented too proud.The patient hip joint was believed to be too tight.It was revised to a smaller size stem and placed with more anteversion.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.

Event Description

It was reported that patient underwent a left hip arthroplasty.Subsequently, the patient was revised approximately 2.5 weeks later due to recurrent dislocations.While attempting to reduce the hip, a significant abduction contracture was noted, and the patient dislocated again while in a knee immobilizer and using an abduction pillow.During the revision, a large hematoma and necrotic tissue was debrided, the posterior capsular repair was found ruptured, and the previous stem was found to have no anteversion and 3-4degrees of retroversion.A new stem was cemented into place with a new head.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: ZB 12/14 COCR HD 28MM X -3.5
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13110771
• MDR Text Key: 282924110
• Report Number: 0001822565-2021-03693
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• 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: 802202801
• Device Lot Number: 3035224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male