MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: femoral head 12/14 taper, pn: 00801803603, ln: 61192708.Liner standard 3.5 mm offset 36 mm, pn: 00630505036, ln: 61281054.Femoral stem fiber metal midcoat collarless 12/14 neck taper, pn: 00784501220, ln: 60283141.Shell porous with cluster holes, pn: 00620205222, ln: 61305013.The event was confirmed with medical records received.Review of the available records identified the following: primary op notes were reviewed and no complications were noted.Revision op notes were reviewed and identified: recurrent dislocation, right total hip.Patient had feeling of popping and instability.Although she never presented to the ed with a dislocation requiring reduction, she was able to voluntarily dislocate her hip in the office.Films showed adequate position of the implant, except for some less than ideal anteversion of the cup.Joint fluid clear but capsular tissue was stained black with metal debris.Posterior superior lip of the polyethylene liner was cracked and broken.The stem appeared to be well ingrown.It was well positioned in 15 degrees of anteversion.There was abundant pseudocapsule, which appeared inflamed but not infected although it was stained with debris.The locking mechanism was jammed.This required fragmenting the liner with osteotomes and removing in pieces.The head of the acetabular screw stripped out during removal.The screw was eventually removed with pencil tip burr and pliers.The trabecular metal shell had close to 100% bony ingrowth.The acetabulum was then prepped for competitors product.The final ceramic head was assembled and impacted on a clean dry morse taper.The hip was reduced.There was no change in limb length or stability as compared with the trial reduction.The wound was lavaged with dilute betadine solution then normal saline.The wound was closed in layers.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04556, 0001822565-2019-04557, 0002648920-2019-00764, 0002648920-2019-00765.

Event Description

It was reported a patient underwent an initial right tha.Subsequently, the patient was revised approximately 9 years after the initial due to instability, dislocation, implant fracture, pseudocapsule/pseudotumor, adverse local tissue reaction, migration, and tissue damage.Medical records indicate that during the revision procedure, it was noted that there was clear joint fluid but the capsular tissue was stained black with metal debris.Further, the posterior superior lip of the polyethylene liner was fractured.Additionally, the head of the acetabular screw stripped out during removal.No further event information available at the time of this report.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
• Type of Device: BONE SCREW
• 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: 9781437
• MDR Text Key: 187717521
• Report Number: 0002648920-2020-00152
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2019
• Device Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: 61233964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention