MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACETABULAR DOME HOLE PLUG; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)

Catalog Number 2060-0000-1

Device Problems Device Contamination with Chemical or Other Material (2944); Material Distortion (2977); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported 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.Not available.

Event Description

It was reported that, during a tha, when a nurse opened the package, a surgeon found a threadlike metal with the plug.A spare was used instead.

Manufacturer Narrative

An event regarding damage involving a dome hole plug was reported.The event was confirmed.The device was returned with the package and ifu and product labels for a cancellous bone screw.There is damage noted on the threads of the plug.Review of the device with a material analysis engineer indicated, "damage observed on threads of plug, consistent with use and cross-threading.Metal thread also observed on plug." medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.No other events were reported for the lot indicated.The reported event was confirmed by the visual inspection and material analysis review however, the root cause could not be determined as the device was deemed to be damaged from use.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that, during a tha, when a nurse opened the package, a surgeon found a threadlike metal with the plug.A spare was used instead.

• Brand Name: ACETABULAR DOME HOLE PLUG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7051262
• MDR Text Key: 93181814
• Report Number: 0002249697-2017-03388
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: 07613327037067
• UDI-Public: 07613327037067
• Combination Product (y/n): N
• PMA/PMN Number: K920868
• 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: 01/17/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Catalogue Number: 2060-0000-1
• Device Lot Number: 972TTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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