MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X20 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problems Failure to Osseointegrate (1863); Osseointegration Problem (3003)

Patient Problems Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803202-femoral head sterile product do not resterilize 12/14 taper-61484661, 00771101200-ml taper sz12.5 std offset-61422470, 00620005422-shell porous with cluster holes 54 mm o.D.- 61439125, 00625006530-bone scr 6.5x30 self-tap-61445389, 00630505032-liner standard 32 mm i.D.For use with 50/52/54 mm o.D.Shells-61405092, 0022320128-cable cerclage cable with crimp 1.8 mm dia.635 mm length-61251774.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00407, 0001822565-2021-00377, 0002648920-2022-00081 and 0002648920-2022-00083.Reported event was confirmed via medical records reviewed by a health care professional.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive 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 that patient underwent a revision procedure 17 years¿ post-implantation due to pain and elevated metal ions.During the revision, significant trunnionosis was noted with tears in the gluteus medius and minimus.The acetabular cup was aseptically loose with only fibrous but no bony ingrowth.Black metallosis noted around the head and neck.Gluteus medius and minimus were found to be partially torn.The femoral stem was left intact; all other components were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: BONE SCR 6.5X20 SELF-TAP
• 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: 14074600
• MDR Text Key: 289013810
• Report Number: 0002648920-2022-00082
• Device Sequence Number: 1
• Product Code: MRA
• 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,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2019
• Device Model Number: N/A
• Device Catalogue Number: 00625006520
• Device Lot Number: 61336952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG