MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Pain (1994); Tentorial Tears (2097)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: 0001822565-2019-02918.

Event Description

It was reported the patient underwent a revision procedure approximately 7 years post implantation due to pain, elevated ion metals, and tendon tears.It was noted the neck, head, and liner were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed with operative notes provided.The revision operative note for the left hip demonstrated that the patient was revised due to pain, liner wear and elevated metal ion levels.On opening the capsule, the rim of the liner was found fractured, and somewhat mobile posterior superiorly.Upon opening the capsule, there was a minimum of intraarticular debris.The head was removed and significant corrosion about both trunnion and inside of the head.The locking ring did not function properly.The tines were spread.The fracture was isolated to the posterolateral aspect and was noted to occupy about 60 degrees of the circumference of the rim.The locking mechanism was bent and it did not open freely.The locking ring was removed, new locking ring and liner were implanted.The cup was somewhat retroverted and well-fixed.New biolox head was implanted after the black corrosion on the trunnion was cleaned.Review of the device history record identified no deviations or anomalies would contribute to 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.Multiple mdr reports were filed for this event: 0001822565-2019-03470, 0001822565-2019-03473, 0001822565 - 2019 ¿ 02918.

• Brand Name: FEMORAL HEAD STERILE PRODUCT 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: 8784610
• MDR Text Key: 150879060
• Report Number: 0002648920-2019-00519
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: K073499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 62051730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER LINER CAT#00630505036 LOT #62001409; ZIMMER NECK CAT#00784802300 LOT#62010501; ZIMMER SHELL CAT#00620205222 LOT#62047996; ZIMMER STEM CAT#00771300700 LOT#61768419; ZIMMER LINER CAT#00630505036 LOT #62001409; ZIMMER NECK CAT#00784802300 LOT#62010501; ZIMMER SHELL CAT#00620205222 LOT#62047996; ZIMMER STEM CAT#00771300700 LOT#61768419
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 81