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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a few items were explanted.The surgery was not delayed and the patient was not harmed.
Event or Problem Description
It was reported that a few items were explanted due to infection.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A clinical investigation concluded that a patient required a total hip arthroplasty revision of the head and liner approximately 3 weeks post implantation due to infection.It was reported that the surgery was not delayed and the patient was not harmed.It was further communicated that no further clinical information is available.The patient impact beyond the revision cannot be concluded.A lab analysis revealed no visible damage on the retainer ring or the full locking ring.No significant damage was observed on the articular surface or taper of the femoral head.Light scuffs and scratches are likely associated with the removal of the implant.Some biological debris and residue was observed along the rim of the internal liner where it contacts the bipolar shell.Based on the provided information, the reported infection was the contributing factor which led to the revision procedure.A dimensional evaluation revealed both devices are to print specification.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.A review of the sterilization records revealed the product was sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.No further medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.

• 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: 6992296
• Report Number: 1020279-2017-00951
• Device Sequence Number: 782410
• Product Code: KWY
• UDI-Device Identifier: 03596010492500
• UDI-Public: 03596010492500
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2018

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: 05/22/2026
• Device Catalogue Number: 71322051
• Device Lot Number: 16EM19446A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017; 10/11/2017; 10/11/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 11/09/2017; 11/10/2017; 04/24/2018
• 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: Required Intervention