MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Necrosis (1971); Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00630505036 liner standard 3.5 mm offset 36 mm i.D.62328404, 00771101020 femoral stem 12/14 neck taper plasma sprayed 62302391, 00625006530 bone scr 6.5x30 self-tap 62318802, 00620005222 shell porous with cluster holes 52 mm o.D 62268615.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04622 stem, 0002648920 - 2019 - 00778 screw, 0002648920 - 2019 - 00779 shell.

Event Description

It was reported that the patient underwent a revision surgery four years post initial tha due to a loose acetabular component.During the surgery, it was discovered that there were indications of corrosion on the head and stem.Attempts were made to obtain additional information; however, none was available.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Initial op notes demonstrated that the patient had right tha due to degenerative joint disease.No complications and only one screw was installed.Revision op notes demonstrated that the patient was revised due to cup loosening and subsidence with bone loss.During the revision, milky turbid fluid in the joint, the cup rotated 90 degrees from its ideal location.Stem well fixed.Corrosion on the trunnion.Broken screws in the acetabulum.Necrotic tissue.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.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 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
• MDR Report Key: 9243747
• MDR Text Key: 163966749
• Report Number: 0002648920-2019-00777
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 62378517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention