MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CONSTRAINED ACETABULAR INSERTS; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	2099-2858
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Rep provided a usage sheet which showed a series ii liner as wasted.Rep reported that the surgeon had tried that liner first, but it wasn't stable.Surgeon then tried the second liner originally reported.A screw, also wasted, was only used to remove the 2 reported liners.Update 26-jul-2018: rep addressed the report of the series ii liner being unstable: "the instability was related to the rom and likely associated to the patients soft tissue anatomy from revision surgery.It was not related to the implant".The series ii implant was disposed by the hospital.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a constrained acetabular insert was reported.The event was not confirmed., however the device was identified to be fractured from the intraoperative removal process.Method & results: device evaluation and results: visual inspection: a review by a material analyst noted: "ma - liner was fractured, likely due to the intraoperative removal process.No further evaluation could be performed due to the damage on the liner.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." dimensional inspection not performed due the damage observed during visual inspection.Functional inspection: not performed as the device failure modes can not be replicated.Material analysis: a review by a material analyst noted: "ma - liner was fractured, likely due to the intraoperative removal process.No further evaluation could be performed due to the damage on the liner.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: no medical records were received for review with a clinical consultant.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
Rep provided a usage sheet which showed a series ii liner as wasted.Rep reported that the surgeon had tried that liner first, but it wasn't stable.Surgeon then tried the second liner originally reported.A screw, also wasted, was only used to remove the 2 reported liners.Update 26-jul-2018: rep addressed the report of the series ii liner being unstable: "the instability was related to the rom and likely associated to the patients soft tissue anatomy from revision surgery.It was not related to the implant".The series ii implant was disposed by the hospital.

• Brand Name: CONSTRAINED ACETABULAR INSERTS
• 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: 7788317
• Report Number: 0002249697-2018-02552
• Device Sequence Number: 2336342
• Product Code: KWZ
• UDI-Device Identifier: 07613327031584
• UDI-Public: 07613327031584
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 2099-2858
• Device Lot Number: EJ85N0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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: 73 YR