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

Catalog Number S-1400-HH84

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Not available.

Event Description

The patient had multiple dislocations post implant.During revising the case it was found that the 28mm head and mdm x3 disassociated.The polly was floating freely in the hip.

Manufacturer Narrative

An event regarding disassociation involving a metal head was reported.The event was confirmed following visual inspection of the returned device.Method & results: -device evaluation and results: visual inspection: the metal head was returned disassociated from the adm liner.The metal head had some scratches on its articulating surface.Dimensional inspection.The device was inspected as per igs-0002504 ver.16 and found to be within dimensional specification.-medical records received and evaluation: not performed as no medical records were provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays are needed to further investigate the event.If additional information becomes available, this investigation will be re-opened.

Event Description

The patient had multiple dislocations post implant.During revising the case it was found that the 28 mm head and mdm x3 disassociated.The polly was floating freely in the hip.

• Brand Name: C-TAPER LFIT INTER HEAD
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5913851
• MDR Text Key: 53481573
• Report Number: 0002249697-2016-02783
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910988
• 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: 05/10/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: S-1400-HH84
• Device Lot Number: MKR0HA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 120