MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CONSTRAINED ACETABULAR INSERTS; IMPLANT

Catalog Number 2099-2254

Device Problems Mechanical Problem (1384); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

When surgeon went to seat a new constrained liner (b)(4), lot ap8l1r the liner would not lock in place - after several attempts to seat the liner, surgeon opted to cement in next size down liner instead and completed the case.

Manufacturer Narrative

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

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot visual inspection: the subject device was returned assembled with the head and with the locking wire still attached to the insert.Scratching was observed on the insert at multiple locations in the vicinity where the wire is seated.The bearing wire came back disassociated from the insert.The investigation concluded that the scratches observed on the insert where the wire was seated was consistent with the tabs of the acetabular cup not being able to properly engage to the insert.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

When surgeon went to seat a new constrained liner p#2099-2254, lot ap8l1r the liner would not lock in place - after several attempts to seat the liner, surgeon opted to cement in next size down liner instead and completed the case.

• Brand Name: CONSTRAINED ACETABULAR INSERTS
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4844113
• MDR Text Key: 5912001
• Report Number: 0002249697-2015-01942
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 2099-2254
• Device Lot Number: AP8L1R
• Other Device ID Number: STERILE LOT# MSLPE18A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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 Outcome(s): Other
• Patient Age: 92 YR
• Patient Weight: 59