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

Catalog Number 1440-2011

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

End user has reported that the adaptor remained stuck into the tritanium shell and they could not disassemble it.Therefore they had to open a new cup.

Manufacturer Narrative

An event regarding a disassembly issue for a cup impactor bolt from an associated shell was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: the bolt was returned assembled with the trident shell.The device was visually unremarkable.Medical records received and evaluation: not performed as no medical records were provided.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been two other similar events for the lot reported.Conclusions: the event was confirmed.It has been confirmed that this event is within the scope of capa.The capa investigation concluded insufficient assembly instructions and training on a fairly new product to be the root cause of the problem.

Event Description

End user has reported that the adaptor remained stuck into the tritanium shell and they could not disassemble it.Therefore they had to open a new cup.

• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7129088
• MDR Text Key: 95750662
• Report Number: 0002249697-2017-03613
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

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: 08/31/2021
• Device Catalogue Number: 1440-2011
• Device Lot Number: DC 259356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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