MAUDE Adverse Event Report: BIOMET ORTHOPEDICS HIP MOLD STEM W/REINF 9X200; PROSTHESIS, HIP

Model Number N/A

Device Problem Bent (1059)

Patient Problem Hip Fracture (2349)

Event Date 06/10/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

The patient underwent the first stage of a two stage revision and was implanted with cement spacer molds.Within four weeks post-op, the patient was revised due to the spacer mold stem bending and femoral fracture.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

The patient underwent the first stage of a two stage revision and was implanted with cement spacer molds.Patient underwent a revision procedure approximately 2 months post-implantation due to the spacer mold stem bending and femoral fracture.

Manufacturer Narrative

The head, femoral component and neck adapter were returned and evaluated.The visual inspection confirmed that the femoral component is fractured in two places.The mar identified a burnished area on the head possibly due to wear.In addition there are surface bubbles on the head.The stem appears to be well formed without signs of overfilling distortion.There are gouges on the proximal end of the stem, likely caused when it was removed.It also appears that bone cement was added to the proximal stem after it was removed from the mold.The extra bone cement may have been used to attach the stem to the proximal femur.The stem spacer is bent in two locations at different angles with the surrounding cement cracked.The stem reinforcement does not appear fractured and can be seen between the cement cracks.It is possible the stem bent as a result of the femoral fracture.The spacer's indicated use is for only non-load bearing situations, and it is possible the bent stem probably occurred during load bearing.Review of the dhr and deviation history for each product did not identify any related deviations.Therefore, the root cause cannot be determined.Review of complaint history found no additional related issues for this item review of device history records found these units were released to distribution with no deviations or anomalies.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: hip neck length adapter +6 mm p/n 431187 l/n 972230, 56 mm head hip mold w/insert p/n 431183 l/n 906940.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 corrected information.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: HIP MOLD STEM W/REINF 9X200
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5786071
• MDR Text Key: 49294888
• Report Number: 0001825034-2016-02557
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/24/2019
• Device Model Number: N/A
• Device Catalogue Number: 431195
• Device Lot Number: 740340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention