MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 36MM/+2.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	06-3625
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/18/2018
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 relevant discrepancies.Based on the device identification, the complaint databases were reviewed for similar reported events regarding pain.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Revision of acetabular component.Update 20/jul/2018: as reported by rep: patient had a painful hip for years.Surgeon would like the head checked for wear.Head, liner, and shell were revised.

• Brand Name: C-TAPER COCR LFIT HEAD 36MM/+2.5MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7785652
• Report Number: 0002249697-2018-02543
• Device Sequence Number: 13968461
• Product Code: LPH
• UDI-Device Identifier: 07613327032796
• UDI-Public: 07613327032796
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: 01/31/2014
• Device Catalogue Number: 06-3625
• Device Lot Number: METHA3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/15/2018
• 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: 73 YR
• Patient Weight: 99