MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM TRIAL CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1235-0-522

Device Problems Break (1069); Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

During surgery the trail cup became stuck in patient of which the handle broke off and part of the trail cup when trying ot get it out.

Manufacturer Narrative

An event regarding a size/fit issue involving an adm cup trial was reported.The event was not confirmed.Method and results: device evaluation and results: deformation was observed on the trial cup, consistent with the explantation process.The device was otherwise visually unremarkable.The device was found to be dimensionally compliant.Medical records received and evaluation: not performed as medical records were not received for evaluation.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: a review of the complaint history database shows that there have been no other reported events for the subject lot code.Conclusions: the device was measured on return and was found to be dimensionally compliant.The exact cause of this event however could not be determined based on the available information.Further information such as medical records and operative reports are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

During surgery the trail cup became stuck in patient of which the handle broke off and part of the trail cup when trying ot get it out.

• Brand Name: RESTORATION (TM) ADM TRIAL CUP
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6039988
• MDR Text Key: 57877107
• Report Number: 0002249697-2016-03255
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• 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,Followup
• Report Date: 09/20/2016

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 Catalogue Number: 1235-0-522
• Device Lot Number: G3113947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR