MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COLLARLESS BI-METRIC POROUS STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547); Physical Resistance/Sticking (4012)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - m2a-magnum mod hd sz 48mm/ pn 157448/ ln 164140, m2a-magnum pf cup 54odx48id/ pn us157854/ ln 708300, m2a-magnum 42-50mm tpr insrt-6/ pn 139252/ ln 168650.Once the investigation has been completed, a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03103.

Event Description

It was reported that during a revision surgery, the surgeon was unable to remove the head/taper from the stem which required stem removal.The cup position required adjustment for stability and was also removed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed through review of medical records.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 revision surgery, the surgeon was unable to remove the head/taper from the stem which required stem removal.The cup position required adjustment for stability and was also removed.Additional information received in revision operative report noted that the head was cold-welded to the stem.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) ¿ stem.One stem and one insert were returned with the lots not confirmed.Upon visual inspection the head and the stem are stuck together and could not be separated so the lot of the stem could not be confirmed.The lot of the head and the insert have gouging with the lot not being able to be seen.The investigation could not verify or identify any evidence of product contribution to the reported problem.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: COLLARLESS BI-METRIC POROUS STEM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6552738
• MDR Text Key: 74681977
• Report Number: 0001825034-2017-03102
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: X180313
• Device Lot Number: 113120
• Other Device ID Number: N/A
• 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: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 76 KG