MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP MOLD STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Markings/Labelling Problem (2911); Inaccurate Information (4051)

Patient Problem No Code Available (3191)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Report source: (b)(6).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 hip revision that the size on the stem space mold was incorrect.After rasping was complete it was determined that the size on the box was two sizes smaller than the actual size of the stem space mold itself.Therefore, additional rasping was required and the surgery was completed with a larger size implant than the surgeon initially intended.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1, a2, e1-e4; h2; h3; h6 reported event was confirmed with photos provided.No product was returned; visual and dimensional evaluations could not be performed.Supplied photos show 13 engraved on taper of stem.No medical records were provided.Review of the device history record(s) identified no related deviations or anomalies during manufacturing.The root cause of the reported issue is traced to manufacturing deficiency.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: HIP MOLD STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8942191
• MDR Text Key: 155935614
• Report Number: 0001825034-2019-03809
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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: 05/02/2024
• Device Model Number: N/A
• Device Catalogue Number: 431191
• Device Lot Number: 478430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention