MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H10 NARRATIVE; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted concomitant medical products: item number: unknown, item name: unknown trabecular metal cluster shell, lot #: unknown; item number: unknown, item name: unknown zimmer m/l taper cementless stem, lot #: unknown; item number: unknown, item name: unknown head, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 05101, 0001822565 - 2018 - 05108.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient was revised due to pain, swelling, elevated ion levels, infection and severe adverse reaction to metal debris.All implants were removed and replaced.Attempts have been made and no additional information is available.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting revision surgery due to pain and recurrent dislocation.During the procedure, the acetabular component was noted to have excessive anteversion and the joint had extensive connective tissue necrosis.The patient underwent a second stage revision due to infection, elevated metal ions, and pain.Dhr was reviewed and no discrepancies were found.Additional information does not change the final results of previous investigation.Root cause was unable to 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

No additional event information to report at this time.

Event Description

It was reported that patient underwent 2nd revision approximately 8 years post initial implantation.The patient underwent staged revision procedures due to elevated metal ions and continued pain.During the revision, extensive necrosis consistent with adverse reaction to metal debris was noted.During the first stage all existing implants were removed, and a depuy spacer was placed with palacos cement.The second stage, performed approximately 2 months later exchanged the cement spacer for a new competitor spacer with palacos cement and cerclage wires were removed.One month later, the third stage occurred in which the spacer was removed and reimplantation occurred.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Constrained liner with constraining ring use with trilogy and trabecular metal modular acetabular systems 28 mm i.D.For use with 50/52/54 mm o.D.She.Concomitant medical products: item# 00771100710 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 standard offset reduced neck length lot# 60926658.Item# 00620205022 shell porous with cluster holes 50 mm lot# 00112247.Item# 00620105200 52mm replacement lock ring lot# 62911635.Item# 00801802803 femoral head sterile product do not resterilize 12/14 taper lot# 62542670.Additional mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 03072, 0002648920 - 2019 - 00542.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b7; d4; g4; h2; h3.Review of the dhr for the new corrected device was performed and no discrepancies were found.Additional information received does not change the final conclusions of the previous investigation.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: SEE H10 NARRATIVE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7895641
• MDR Text Key: 120962349
• Report Number: 0001822565-2018-05102
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: K071718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00633405028
• Device Lot Number: 63470106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2020
• 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