MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 60MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-3260
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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 or Problem Description
During a primary implant procedure, cemented constrained cup dislocated during case.Bipolar had to be reduced back into cemented cup and another head was used.
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event was not confirmed.
Event or Problem Description
During a primary implant procedure, cemented constrained cup dislocated during case.Bipolar had to be reduced back into cemented cup and another head was used.

• Brand Name: ALL POLY CONSTRAINED INSERT 60MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6847146
• Report Number: 0002249697-2017-02690
• Device Sequence Number: 13833640
• Product Code: KWZ
• UDI-Device Identifier: 07613327025507
• UDI-Public: 07613327025507
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2021
• Device Catalogue Number: 69-3260
• Device Lot Number: 7X3A17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 91