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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 12 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 12 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 71309012
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Date 05/25/2020
Event Type  Injury  
Event Description
Us legal mdl. It was reported that the patient underwent medically indicated revision of the bhr cup and the cobalt-chronium modular head of the right hip on (b)(6) 2020. The patient revision surgery was performed due to severe pain, limited mobility, metallosis, elevated cobalt and chromium levels, and adverse local tissue reaction. Intra-operative findings from the revision surgery performed indicate large fluid collection in hip joint. The stem was also revised due to inadequate stability. The patient was stable after the procedure.
 
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Brand NameSYN POR PLUS HA SO STEM SZ 12
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11849376
MDR Text Key251433239
Report Number1020279-2021-04452
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/27/2018
Device Model Number71309012
Device Catalogue Number71309012
Device Lot Number08DM06509A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/29/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/19/2021 Patient Sequence Number: 1
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