MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 32MM/0; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Model Number	06-3200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hair Loss (1877); Pain (1994); Reaction (2414); Ambulation or Postural Difficulties (2544)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient called and stated that she has been experiencing pain, immobility, pain in her groin, back pain, metallosis and hair loss since her left hip surgery on (b)(6) 2006.
Additional Manufacturer Narrative
This record is a duplicate of mfr#2249697-2012-00836; therefore, this is being cancelled.
Event or Problem Description
Patient called and stated that she has been experiencing pain, immobility, pain in her groin, back pain, metallosis and hair loss since her left hip surgery on (b)(6) 2006.

• Brand Name: C-TAPER COCR LFIT HEAD 32MM/0
• Common Device Name: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7996528
• Report Number: 0002249697-2018-03479
• Device Sequence Number: 203356
• Product Code: LWJ
• UDI-Device Identifier: 07613327016291
• UDI-Public: 07613327016291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 04/30/2016
• Device Model Number: 06-3200
• Device Catalogue Number: 06-3200
• Device Lot Number: MKHT72
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 06/30/2020
• 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: 46 YR
• Patient Weight: 58