MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 51OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71322051
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	12/15/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2015, the patient was admitted for increased popping and drainage in joint.On (b)(6) 2015, the patient underwent a closed reduction under anesthesia.On (b)(6) 2015, the patient underwent a closed reduction under anesthesia.On (b)(6) 2015, the patient underwent a hip aspiration.On (b)(6) 2015, the patient underwent a revision surgery to remove the construct due to an infected unstable left hip.
Additional Manufacturer Narrative
Additional information: the associated complaint devices were not returned.A clinical analysis indicates that based on the information provided, unable to rule out the patient¿s extensive medical/surgical history, persistent periprosthetic joint infection, significant high-risk comorbidities, frequency of admissions, the reported iliopsoas tenotomy and posterior approach in the presence of neuromuscular/connective tissue disorder as possible contributing factors to the reported events.The patient impact beyond the reported acute on chronic pain, recurrent dislocations, persistent infection, and revision procedures cannot be concluded.Per documentation the patient continued to experience recurrent dislocations with suspected persistent prosthetic joint infection.No further medical assessment can be rendered at this time.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 part revealed no prior complaints for the listed batch with the same failure mode.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: TANDEM BIPOLAR COCR 51OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7119523
• Report Number: 1020279-2017-01262
• Device Sequence Number: 1156173
• Product Code: KWY
• UDI-Device Identifier: 03596010492500
• UDI-Public: 03596010492500
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2017
• Device Catalogue Number: 71322051
• Device Lot Number: 07GM19437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention