MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FEM RED LAT NC 15X155; PROSTHESIS, HIP

Catalog Number 192515

Device Problem Inaccurate Information (4051)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

It was reported while selecting items for a procedure, the stem was found to be labeled incorrectly.There was no patient involvement.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).G2: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4; b5; g3; h2; h3; h6.Review of the dhr label identified the device is labeled as ¿echo press fit¿.However, review of the master label identified the device is labeled as ¿echo bi-metric¿, which is correct.The product was confirmed to be mislabeled by review of the manufacturing records.Review of the dhr found, ncr12372234 for mislabeled devices, which could be related to the reported event.The investigation results concluded that the reported event was due to the condition of the device when it left zimmer biomet as being considered non-conforming to specification.The root cause of the reported event can be attributed to a labeling issue.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 to report at this time.

• Brand Name: ECHO POR FEM RED LAT NC 15X155
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17009467
• MDR Text Key: 316006057
• Report Number: 0001825034-2023-01199
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868260902
• UDI-Public: (01)00887868260902(17)280804(10)725440
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 192515
• Device Lot Number: 725440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1