MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X25 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Migration (4003)

Patient Problems Ossification (1428); Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 00801803602, lot: 61092931, femoral head 12/14 taper, part: unk, lot: unk, hip-m / l taper-stems-unk, part: unk, lot: unk, kinectiv modular neck, part: 00620205422, lot: 61301468, shell porous with cluster holes 54 mm, part: 00630505036, lot: 61294231, liner standard 3.5 mm offset 36 mm i.D.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00336, 0001822565-2021-02939, 0001822565-2021-02953, 0001822565-2021-02955, 0002648920-2021-00344.

Event Description

It was reported that the patient was revised 7 years post-implantation due to instability, and dislocation.Surgeon noted corrosion, joint laxity, poly liner fracture, cup migration and heterotopic ossification at the cup.The surgeon was unable to disengage head, and eto was performed and stem removed.All components explanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records for the screw, shell, liner, and head identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a revision was performed on sep 12, 2016 due to dislocations and instability.A ct scan revealed the femoral component was retroverted, as well as the shell.Ligament laxity was noted.The liner was fractured and corrosion found between the head/neck taper.When attempting to remove the head, the neck and stem disengaged.All products were explanted and replaced with competitor products.No complications noted. the root cause is unknown.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

No further event information available at the time of this report.

• Brand Name: BONE SCR 6.5X25 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: 12617244
• MDR Text Key: 275954926
• Report Number: 0002648920-2021-00337
• Device Sequence Number: 1
• Product Code: HWC
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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: 08/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: 61307750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male