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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Blood Loss (2597); Osteopenia/ Osteoporosis (2651); Patient Problem/Medical Problem (2688)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

Brand name: femoral stem fiber metal taper collarless 12/14 neck taper size 13 lm body extended neck offset.Concomitant medical products: item #: unknown unknown head lot #: unknown, item #: unknown unknown cup lot #: unknown.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 - 04514head, 0001822565 - 2019 - 04515shell.

Event Description

It was reported that an initial right total hip arthroplasty performed and subsequently underwent revision of the head and liner due to complications from trunnionosis seven years later.The patient then underwent a second revision due to pain, wound complications, and radiolucency with apparent acetabular screw fracture on x-ray.After the second revision, the patient fell due to unknown reasons and suffered an acetabular protrusion.A third revision was performed a month after the second revision during which all components were removed and a girdlestone procedure was performed.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D11: multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00517 liner.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.Medical records identified zimmer biomet components were implanted without complications.The patient underwent a revision procedure due to trunnionosis.The patient underwent a second revision procedure due to pain, wound complications and radiolucency.Following second revision, the patient fell and suffered acetabular protrusion, and underwent another revision surgery.During the procedure, a protrusion was noted to be putting pressure on the iliac artery graft causing mild kinking but no compromise to the circulation in the lower extremity.Cultures were negative for infection.The superior arch appeared to be intact, but anterior and posterior walls were rather weak and the whole of the medial wall was completely blown out with a bipolar component protruding into the pelvis.All zimmer biomet components were removed and a girdlestone procedure was performed.Blood loss of 800ml, prbcs transfused.No other findings related to the reported event were noted.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: SEE H10 NARRATIVE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9212540
• MDR Text Key: 162996681
• Report Number: 0001822565-2019-04512
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K964769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

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: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00786201350
• Device Lot Number: 07886766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/20/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Weight: 78