REJUVENATE SPT MODULAR STEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for REJUVENATE SPT MODULAR STEM manufactured by Stryker Corp..

Event Text Entries

[181979791] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5093335
MDR Report Key	9763879
Date Received	2020-02-26
Date of Report	2020-02-24
Date of Event	2014-01-03
Date Added to Maude	2020-02-27
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	REJUVENATE SPT MODULAR STEM
Generic Name	PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED METAL/POLYMER
Product Code	MEH
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0
Manufacturer	STRYKER CORP.

Device Sequence Number: 2

Brand Name	TRIDENT POLYETHYLENE INSERT / CLUSTER-HOLE SHELL
Generic Name	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS, UNCEMENTED
Product Code	LPH
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	2
Device Event Key	0
Manufacturer	STRYKER CORP.

Device Sequence Number: 3

Brand Name	TRIDENT POLYETHYLENE INSERT / CLUSTER-HOLE SHELL
Generic Name	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS, UNCEMENTED
Product Code	LPH
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	3
Device Event Key	0
Manufacturer	STRYKER CORP.

Device Sequence Number: 4

Brand Name	BONE SCREWS
Generic Name	SCREW, FIXATION BONE
Product Code	HWC
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	4
Device Event Key	0
Manufacturer	UNK
Manufacturer Address	UNK UNK

Device Sequence Number: 5

Brand Name	BONE SCREWS
Generic Name	SCREW, FIXATION BONE
Product Code	HWC
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	5
Device Event Key	0
Manufacturer	UNK
Manufacturer Address	UNK UNK

Device Sequence Number: 6

Brand Name	BONE SCREWS
Generic Name	SCREW, FIXATION BONE
Product Code	HWC
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	6
Device Event Key	0
Manufacturer	UNK
Manufacturer Address	UNK UNK

Device Sequence Number: 7

Brand Name	BIOLOX DELTA CERAMIC FEMORAL HEAD/WAGNER SL STEM/POLYETHYLENE LINER
Generic Name	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Product Code	LZO
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	7
Device Event Key	0
Manufacturer	STRYKER CORP.

Device Sequence Number: 8

Brand Name	BIOLOX DELTA CERAMIC FEMORAL HEAD/WAGNER SL STEM/POLYETHYLENE LINER
Generic Name	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Product Code	LZO
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	8
Device Event Key	0
Manufacturer	ZIMMER BIOMET

Device Sequence Number: 9

Brand Name	BIOLOX DELTA CERAMIC FEMORAL HEAD/WAGNER SL STEM/POLYETHYLENE LINER
Generic Name	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Product Code	LZO
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	9
Device Event Key	0
Manufacturer	ZIMMER BIOMET

Device Sequence Number: 10

Brand Name	TRIDENT POLYETHYLENE INSERT /CLUSTER-HOLE SHELL
Generic Name	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS, UNCEMENTED
Product Code	LPH
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	10
Device Event Key	0
Manufacturer	ZIMMER BIOMET

Device Sequence Number: 11

Brand Name	BIOLOX DELTA CERAMIC FEMORAL HEAD/WAGNER SL STEM/POLYETHYLENE LINER
Generic Name	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Product Code	LZO
Date Received	2020-02-26
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	11
Device Event Key	0
Manufacturer	ZIMMER BIOMET

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-02-26