MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER INTER.NK HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	S-1400-HH34
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Reaction (2414)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.Device not returned.
Event or Problem Description
It was reported that patient's right hip was revised due to elevated cobalt and chromium levels after patient complaint of severe pain since 2013.Intra-operatively, trunnionosis was noted.The head and liner were exchanged for a 36e liner and size 36 ceramic head with a +5 adapter sleeve - stem was cleaned off and retained.

• Brand Name: C-TAPER INTER.NK HEAD
• 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: 7937986
• Report Number: 0002249697-2018-03215
• Device Sequence Number: 1936429
• Product Code: JDI
• UDI-Device Identifier: 07613327016734
• UDI-Public: 07613327016734
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: S-1400-HH34
• Device Lot Number: MHNH91
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/05/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 86