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

Catalog Number 1440-2011

Device Problem Mechanical Jam (2983)

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

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After impacting 56 shell and removing handle, the impactor bolt could not be loosened.Shell loosened in the acetabulum and was removed.Attempts to remove the bolt on the back table were unsuccessful.Surgeon completed implant with other device and no complications.

Manufacturer Narrative

An event regarding a disassembly issue for a cup impactor bolt from an associated shell was reported.The event was confirmed.Conclusions: the event was confirmed.It has been confirmed that this event is within the scope of a capa for exceeded complaint rate for da impactor bolt (p/n 1440-2011) disassembling from cup.A capa investigation concluded the root cause to be a combination of insufficient assembly instructions and the product is fairly new and the user may not have previous practice on the usage of the instrument.

Event Description

After impacting 56 shell and removing handle, the impactor bolt could not be loosened.Shell loosened in the acetabulum and was removed.Attempts to remove the bolt on the back table were unsuccessful.Surgeon completed implant with other device and no complications.

• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6681074
• MDR Text Key: 78833959
• Report Number: 0002249697-2017-02100
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

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 Catalogue Number: 1440-2011
• Device Lot Number: DC242969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• 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: 60 YR
• Patient Weight: 91