MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 16MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 09390116

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into vendor stock with no reported discrepancies.There have been no other similar events for the lot referenced.Device not available.

Event Description

Stryker sales representative reported that 2 cement restrictors broke during insertion.The first time the restrictor split, the surgeon had to manually remove each of the pieces.These were successfully removed from the patient.The second time, on advice from senior surgeon, he opted to leave the restrictor in.The top broke off this particular one but it was so well fixed it was proving difficult to remove.Two different introducers were used.These have been used without issue in previous surgeries.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed by a photograph provided.Conclusions: the exact cause of the event could not be determined with the available information.Return of the reported device for evaluation is required to complete the investigation for determining the root cause.No further investigation for this event is possible at this time as the device was not received by stryker.If additional information becomes available, this investigation will be reopened.

Event Description

Stryker sales representative reported that 2 cement restrictors broke during insertion.The first time the restrictor split, the surgeon had to manually remove each of the pieces.These were successfully removed from the patient.The second time, on advice from senior surgeon, he opted to leave the restrictor in.The top broke off this particular one but it was so well fixed it was proving difficult to remove.Two different introducers were used.These have been used without issue in previous surgeries.

• Brand Name: EXETER 2.5 I M PLUG 16MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6287305
• MDR Text Key: 66119221
• Report Number: 0002249697-2017-00361
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540167248
• UDI-Public: (01)04546540167248(11)150720(17)200731(10)L8415
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K980843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 09390116
• Device Lot Number: L8415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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