MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-52D

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

An event regarding thread damage involving a tritanium shell was reported.The event was confirmed.A visual inspection of the returned device noted that the device was returned in used condition.The threads on the "convex" side of the cup showed signs of having been deformed or "rolled over" towards the inner threads completely distorting the initial thread pattern.Examination of the device by the mar engineer indicated that the device damage observed consistent with cross threading.Medical records received and evaluation: not performed as there are no medical records were provided.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.A visual inspection of the returned device noted that the device was returned in used condition.The threads on the "convex" side of the cup showed signs of having been deformed or "rolled over" towards the inner threads completely distorting the initial thread pattern.Examination of the device by the mar engineer indicated that the device damage observed consistent with cross threading.The cup would not thread on the impactor bolt.The first thread is damaged and would not allow the impactor to thread properly on the cup.The device was acceptable during inspection and there were no other complaints from other devices within this lot.It is likely that the cross threading was due to a user error.

Event Description

During a total hip a 52mm tritanium cluster shell was opened on the sterile field.The scrub tech attempted to thread the direct anterior cup impactor bolt into the threaded dome hole of the shell.She stated that it would not thread.The surgeon then attempted and he stated that it would not thread and to give him a new shell.A new 52mm shell was opened and the bolt was inserted without incidence and cup was implanted.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6398572
• MDR Text Key: 69747577
• Report Number: 0002249697-2017-00863
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327040128
• UDI-Public: (01)07613327040128(11)160929(17210930(10)587TV9
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• 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: 03/13/2017

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 Expiration Date: 09/30/2021
• Device Catalogue Number: 502-03-52D
• Device Lot Number: 587TV9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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
• Patient Age: 61 YR
• Patient Weight: 93