MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPIKED SHELL SZ 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336352

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient underwent a revision surgery for dislocation with exchange of acetabular cup and liner.Patient spontaniously dislocated her hip on several occasions following fall from the hospital bed in (b)(6) 2016.

• Brand Name: REF SPIKED SHELL SZ 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6352219
• MDR Text Key: 68085581
• Report Number: 1020279-2017-00121
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Catalogue Number: 71336352
• Device Lot Number: 10AM12177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided; 02/27/2017
• Supplement Dates FDA Received: 03/07/2017; 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REF INTERFIT THRD HOLE COVER: 71330001/UNKNOWN LOT; REF XLPE 28 20 DEG 50-52 E: 71333324/UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR