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

Model Number	S-1400-HH32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	01/01/2011
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.It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
This pi is for revision of primary.The patient stated she had a right tha done (b)(6) 2007.Patient started to experience pain approx in 2011.In (b)(6) 2020 patient had an mri and blood work done which showed she had high cobalt levels and mri showed large pseudotumors.The patient was revised on (b)(6) 2020.After revision the patient experienced a large hematoma on her right hip.The patient stated the hematoma was drained three times but it keeps coming back.The patient is scheduled for surgery on (b)(6) 2021 to remove the hematoma, any present metals and put a drain for about 5 days.Patient is seeking compensation.

• 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: 11480257
• Report Number: 0002249697-2021-00448
• Device Sequence Number: 3430291
• Product Code: JDI
• UDI-Device Identifier: 07613327016703
• UDI-Public: 07613327016703
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K910988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 05/31/2012
• Device Model Number: S-1400-HH32
• Device Catalogue Number: S-1400-HH32
• Device Lot Number: DPHMJD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/15/2021
• 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: 50 YR
• Patient Weight: 64