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

Catalog Number 71309012

Device Problems Loose or Intermittent Connection (1371); Osseointegration Problem (3003); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/12/2016

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to groin pain, aseptic loosening, need for open reduction and internal fixation of femur.

Manufacturer Narrative

[(b)(4)].

Event Description

Only femoral stem and femoral head were revised during the revision surgery, due to subsidence of the stem.

Manufacturer Narrative

The associated complaint devices were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no additional complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: SYN POR PLUS HA SO STEM SZ 12
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; spa park; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; spa park; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 6885725
• MDR Text Key: 87158476
• Report Number: 3005975929-2017-00314
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K002996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71309012
• Device Lot Number: 16CM10120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR