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

Catalog Number	09390116
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6287305
• Report Number: 0002249697-2017-00361
• Device Sequence Number: 30938
• Product Code: JDI
• UDI-Device Identifier: 04546540167248
• UDI-Public: (01)04546540167248(11)150720(17)200731(10)L8415
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K980843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 09390116
• Device Lot Number: L8415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 04/12/2017
• 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