MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 38OD 22ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71324038
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered a dislocation seven weeks after her hip replacement.
Additional Manufacturer Narrative
The affected cobalt chrome 12/14 taper femoral head, tandem international bipolar and synergy porous stem were not returned for evaluation.Our investigation including a review of complaint history revealed no additional complaints for the listed batches with the same failure mode.The devices were manufactured in 2016 and 2017.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that without the explant analysis and based solely on the unidentified copy of the radiological image, the exact cause of the inferolaterally displaced cup/head could not be determined.The non-radiopaque retention ring cannot be identified on the provided image.Although trauma was not reported, it is unknown if it was a precursor to such a significant dislocation.The patient impact was the reported dislocation, revision procedure, expected pain/discomfort, and a post-revision rehabilitation phase.No further medical assessment can be rendered at this time.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: TANDEM INTL BIPOLAR 38OD 22ID
• 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: 7962884
• Report Number: 1020279-2018-02128
• Device Sequence Number: 1738914
• Product Code: KWY
• UDI-Device Identifier: 03596010498212
• UDI-Public: 03596010498212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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 Catalogue Number: 71324038
• Device Lot Number: 17HM15424
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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: Other
• Patient Age: 79 YR