MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 1440-2011

Device Problem Mechanical Jam (2983)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

The connection between the bolt and the trident cup was so tight.When the bolt was removed after the cup was placed in the body, it turned together with the cup.Eventually it could not be press-fitted, so a cement cup was used instead.

• Brand Name: CUP IMPACTOR BOLT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11918557
• MDR Text Key: 258985336
• Report Number: 0002249697-2021-00961
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327196245
• UDI-Public: 07613327196245
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

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 Model Number: 1440-2011
• Device Catalogue Number: 1440-2011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90