MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL STEM SIZE 12.5; PROSTHESIS, HIP

Catalog Number 00771101220

Device Problems Defective Component (2292); Component or Accessory Incompatibility (2897)

Patient Problem No Information (3190)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that during a knee arthroplasty the femoral stem was too small to be press in the femoral canal after the surgeon reamed with a broach corresponding to the size of the stem.The surgeon reamed to a larger size and the component fit without issue.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.A m/l taper stem was returned for evaluation.As returned, the stem is in excellent condition.The stem was inspected on comparator confirming size in the a/p and m/l view.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined, as the reported event could not be substantiated.A summary of the investigation has been sent to the complainant.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

It was reported that during a total hip arthroplasty the femoral stem was allegedly too small to be press-fit into the femoral canal after the surgeon reamed with a broach corresponding to the size of the stem.The surgeon reamed to a larger size and the component fit without issue.No additional patient consequences were reported.

• Brand Name: FEMORAL STEM SIZE 12.5
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6598945
• MDR Text Key: 76215669
• Report Number: 0001822565-2017-03670
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK032726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 00771101220
• Device Lot Number: 63186453
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70