MAUDE Adverse Event Report: STRYKER CORP. REJUVENATE SPT MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED METAL/POLYMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Reaction (2414)

Event Date 01/03/2014

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2010, the pt underwent a right total hip arthroplasty with a stryker rejuvenate spt modular stem size 8, trident x3 10-degree polyethylene insert with a 36 mm inside diameter, 54 mm titanium hemispherical cluster-hole-shell, three cancellous bone screws, and biolox delta ceramic v40 femoral head.On (b)(6) 2014, serum / plasma cobalt level was 4.2 mcg/l.On (b)(6) 2014, serum / plasma cobalt level was 5.8 mcg/l.On (b)(6) 2014, serum / plasma cobalt level was 4.7 mcg/l.On (b)(6) 2015, serum/plasma cobalt level was 3.7 mcg/l and urine cobalt level was 2.7 mcg/l.On (b)(6) 2016, serum / plasma cobalt level was 7.8 mcg/l.On (b)(6) 2015, metal suppression mri of the right hip showed no evidence of any concerning reaction.On (b)(6) 2016, repeat metal suppression mri showed pseudotumor involving the superior.Posterior capsules with some extracapsular extension in proximity to the attachment of the gluteus minimus tendon.There is also a small amount of fluid in the trochanteric bursa, tracking towards the joint.On (b)(6) 2016, her right hip ws revised to a zimmer-wagner sl stem with a 36 mm +0 delta ceramic head with a new trident x3 polyethylene liner.The cobalt level of the right hip joint fluid was 310 mcg/l and the chromium level was 140 mcg/l.On (b)(6) 2016, 2 months post revision of the right hip, her serum cobalt level was 0.88 mcg/l and her urine cobalt was not detectable.Fda safety report id # (b)(4).

• Brand Name: REJUVENATE SPT MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED METAL/POLYMER
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 9763879
• MDR Text Key: 181979791
• Report Number: MW5093335
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2020
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR