MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FEM RED LAT NC 19X175; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  Injury  

Event Description

It was reported during a left hip procedure, while implanting the stem surgeon reamed to 0 of greater troch up to 19 broached, up to 19 rpp.Broach had monster bite.Took cross table x-ray.Broach had good diaphyseal and metaphysial fixation.During implantation implant subsided about 4mm.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

(b)(4).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 during a left hip procedure, while implanting the stem surgeon reamed to 0 of greater troch up to 19 broached, up to 19 rpp.Broach had monster bite.Took cross table x-ray.Broach had good diaphyseal and metaphysial fixation.During implantation implant subsided about 4mm.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

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the stem to be in good overall condition.Light scratching was observed around the inserter hole.A small amount of coating has been damaged near the proximal end of the stem.Foreign debris is present in the coating.Discoloration spots are present in the fine coating on the distal end of the stem.Additionally dimensional testing was preformed.The overall length was measured to identify the stem as a 19x175 stem.The measurement fell within the print tolerance.The overall width of the stem was measured at two sections.The depth at the same location was also measured.All measurements are within the stated print tolerances.Complaint sample was evaluated and the reported event was not confirmed.The additional information does not change the outcome 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Visual examination of the provided picture identified there is no visible damage on the stem.Additional visual and dimensional evaluations could not be performed as the device was not returned.The device history records the implant were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: nce12459325 for 2 stems out of tolerance, however they were scrapped and remaining devices were within tolerance.Therefore, it is unlikely that the deviation contributed to the 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.

Event Description

No additional information on the reported event.

• Brand Name: ECHO POR FEM RED LAT NC 19X175
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13235335
• MDR Text Key: 285948004
• Report Number: 0001825034-2022-00084
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 192519
• Device Lot Number: 537470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male