MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 3.5 MM OFFSET 36 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer bioloxa option, head,36/+3.5, taper 12/14 00877703603/ 2764132.Zimmer shell porous with cluster holes 56 mm o.D.00620005622/ 62076918.Zimmer femoral stem fiber metal taper collarless 12/14 neck taper size 13.Zimmer standard body standard neck offset 00786201300/ 62101618.Reported event was confirmed with medical records provided.Op visit notes demonstrated that the patient experienced another dislocation and closed reduction.The patient remains at high risk for dislocation as he has no abductor function for the posterior half of his greater trochanter.Review of the device history record(s) for identified no deviations or anomalies during manufacturing.A definite 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

It was reported the patient underwent an initial right total hip arthroplasty 8 years ago.The patient was revised 2 years ago due to recurrent dislocation and complications from trunnionosis.During the revision, it was noted that severe tissue damage left no abductor function in the hip.The patient subsequently dislocated again and was successfully reduced in the er approximately1 year ago.No further plan for revision has been reported at this time.No further event information available at the time of this report.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10015342
• MDR Text Key: 190653207
• Report Number: 0002648920-2020-00245
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2020

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00630505636
• Device Lot Number: 63279862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• 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 Weight: 107