MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM - REVISION TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Brand name: femoral stem - revision taper nitrided cementless 19 mm diameter 135 mm stem length.Concomitant medical products: 00999302055, femoral body - revision - nitrided - porous cementless 12/14 neck taper extended 46 mm neck offset, 70103800; 00631005836, liner 10 degree elevated rim 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell, 60974593; 00620205822, shell porous with cluster holes 58 mm, 61267401; 00801803604, femoral head sterile product do not resterilize 12/14 taper, 61132301; 00625006540, bone scr 6.5x40 self-tap, 61063124.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00443, 0001822565-2019-02586, 0002648920-2019-00445.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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.

Event Description

It was reported that during revision procedure, it was difficult to remove the cone body from the distal stem and liner from the shell.Removal tools and proximal body disengagement tools failed to remove so the surgeon performed an osteotomy.Proximal body was removed with a punch once all bone had been cleared and the distal portion was removed using trephines, k-wires down the sides and osteotomes.The poly proved difficult to remove and disengage from the acetabular cup but was eventually removed in 1 piece using several instruments.The cup also proved difficult to remove.Using long and short blade explant and curved gouges it was eventually removed.

• Brand Name: FEMORAL STEM - REVISION TAPER
• 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: 8785539
• MDR Text Key: 150857763
• Report Number: 0002648920-2019-00444
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K992667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00998201913
• Device Lot Number: 53620500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 07/12/2019
• 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 Weight: 68