MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-56E

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the cup impaction bolt (1410-2011) became stuck inside tritanium cluster cup (542-11-56f lot 48353101) during acetabular implantation.Neither surgeon nor training registrar could remove the bolt from the cup with removal handles.The tritanium cup and bolt were discarded and a trident psl cup (542-11-56f lot 35169101) was substituted with a standard trident impaction handle with a satisfactory result reported by the surgeon.It was noted that the impaction bolt was removed from the tritanium cup post case by the stryker territory manager.

Manufacturer Narrative

The shell and the bolt were returned disassembled.The returned shell is unremarkable.Conclusion: this event is related to a series of similar reported events where the impactor bolt cannot be disassembled from the associated shell.A capa has been raised to further investigate these events.The preliminary investigation shows these events are associated with a wide variety of shells.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the cup impaction bolt (1410-2011) became stuck inside tritanium cluster cup (542-11-56f lot 48353101) during acetabular implantation.Neither surgeon nor training registrar could remove the bolt from the cup with removal handles.The tritanium cup and bolt were discarded and a trident psl cup ( 542-11-56f lot 35169101) was substituted with a standard trident impaction handle with a satisfactory result reported by the surgeon.It was noted that the impaction bolt was removed from the tritanium cup post case by the stryker territory manager.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5013936
• MDR Text Key: 24587893
• Report Number: 0002249697-2015-02729
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/23/2015

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 502-03-56E
• Device Lot Number: 48353101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2014
• 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): Other