MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI SLEEVE FOR ALUMINA HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	17-0000E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cyst(s) (1800); Injury (2348); Reaction (2414)
Date of Event	08/25/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As per medical records for per (b)(6) stated that " an office visit on (b)(6) 2010 notes the biopsy showed "eosinophils consistent with allergic type reaction but no evidence of sarcoma.".There is an (b)(6) 2010 admission and surgery for excision of the right thigh mass and explant of the right total hip arthoplasty.A discharge summary dated (b)(6) 2010 describes admission on (b)(6) 2010 for excision of mass and "during procedure we determined that the mass had actually transformed most of her normal tissue around hip joint into fibrous necrotic tissue, including her gluteus maximus, medius and minimus, and a large portion of her sciatic nerve.Dead muscle.Excised.Prosthesis.Explanted.Mass extended into pelvis.Not resected due to danger.Pre-op mri pelvic mass nonmalignant".The diagnosis was "ischemic fasciitis, possible pseudotumor".

• Brand Name: TI SLEEVE FOR ALUMINA HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8043266
• Report Number: 0002249697-2018-03631
• Device Sequence Number: 1262874
• Product Code: LZO
• UDI-Device Identifier: 07613327016468
• UDI-Public: 07613327016468
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

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: 03/31/2011
• Device Catalogue Number: 17-0000E
• Device Lot Number: LHJMEA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/06/2018
• 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: Other
• Patient Age: 57 YR
• Patient Weight: 88