MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 52OD 28ID; PROSTHESIS HIP HEMI- FEMORAL METALPOLYMER, CEMENTED OR UNCMENTED

Model Number	71322052
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a tandem shell dislocated from the stem without the head coming off the stem.Retaining ring is reported to be stuck in the shell and could not be removed.Stem remained in the patient.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and the single right hip x-ray labeled post reduction was reviewed.However, it does not contribute to the investigation nor does it aide in the determining the root cause for the reported dislocation.Without the requested clinical information a thorough medical investigation cannot be rendered.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, 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.
Additional Manufacturer Narrative
The devices, used in treatment, were returned for evaluation.A lab analysis visually confirmed damage; scratches on the od the bipolar head and id of the head.The poly liner, poly retaining ring, and lock ring showed no damage.A dimensional evaluation of the critical-to-quality features was completed.The tandem shell and cocr head were within print specifications.The cross-linked polyethylene lock ring was oversized, expectedly due to the reporting of the cocr head passing through the ring and the dislocation.Likely caused warping or stretching of the poly; reflected in the measurements.The retaining ring measured oversized for the tab height; potentially as result of the dislocation assembly potentially warped the ring.The failure mode cannot be confirmed as a manufacturing defect.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation was conducted and confirms that x-ray was reviewed, however, it does not contribute nor aide in determining the dislocation root cause.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, as improper device size selection or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TANDEM BIPOLAR COCR 52OD 28ID
• Common Device Name: PROSTHESIS HIP HEMI- FEMORAL METALPOLYMER, CEMENTED OR UNCMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8205001
• Report Number: 1020279-2018-02935
• Device Sequence Number: 10829121
• Product Code: KWY
• UDI-Device Identifier: 03596010492517
• UDI-Public: 03596010492517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/02/2020

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 Model Number: 71322052
• Device Catalogue Number: 71322052
• Device Lot Number: 17HM07678
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 12/03/2018; 12/03/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 04/03/2019; 03/02/2020; 03/02/2020
• 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