MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 500-03-58F

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

An event regarding assembly issues involving a primary titanium hemi solidback cup 58mm was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of the returned device indicates cross threading was observed due to improper seating of the plug into the shell.There were scratches found in the coated area of the shell.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: indicated that the specified lot was accepted into final stock with no reported discrepancies.Complaint history review: indicated that there have not been any other events for the specified lot.Conclusions: the investigation determined the likely root cause of the assembly issue was cross threading due to improper seating of the plug into the cup.No further investigation is needed at this time.If additional information become available, this investigation will be reopened.

Event Description

When dr.(b)(6) was in inserting the acetabular dome plug in a titanium cup and there was an audible squeak.He was not able to insert the dome plug fully so he tried to remove it.The screwdriver tip broke so he was given another one but could not remove it.Dr.(b)(6) took the titanium cup out and inserted another cup 2mm larger.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 58MM
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5258937
• MDR Text Key: 32459890
• Report Number: 0002249697-2015-04098
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2015

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: 08/30/2020
• Device Catalogue Number: 500-03-58F
• Device Lot Number: KY8ARJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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 Age: 56 YR