MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK G1; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Difficult or Delayed Separation (4044)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00771301100-femoral stem-61304681.00801804002-femoral head-61357247.00630506040-liner standard- 61315782.00620006022-shell porous- 61269962.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00611.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent an initial left total hip arthroplasty.Subsequently, the patient was revised approximately 6 years post implantation.During the procedure significant corrosion was noted at the head/neck junction.An extended osteotomy was performed to remove the well-fixed stem as the neck was cold-welded to the stem.The osteotomy was stabilized with cerclage wires.No further intra-op complications were noted.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6 reported event was confirmed via medical records reviewed by a health care professional.Review of the available records identified the following: during the procedure, it was difficult to disengage the kinectiv neck from the stem and an extended trochanteric osteotomy was performed to the remove the construct.The osteotomy was stabilized with cerclage wires.Review of the device history records identified no deviations or anomalies during manufacturing.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a4; b7; g3; h2; h6.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: MODULAR NECK G1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9712150
• MDR Text Key: 196754882
• Report Number: 0001822565-2020-00609
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 00784802301
• Device Lot Number: 60880035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Weight: 84