MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 44OD 26ID; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325044

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 12/27/2017

Event Type  Injury  

Event Description

It was reported that the patient has dislocation.

Manufacturer Narrative

Please review attached for the investigation results.Investigation results: the associated complaint device was not returned.The clinical/medical team concluded, it was reported that approximately 2 weeks post tha, the patient dislocated.A revision was scheduled for 2 days after the dislocation, however it was communicated that the revision was not performed.There have been multiple attempts to obtain further information regarding a revision and relevant supporting clinical information, however no additional information has been provided.Therefore, a clinical assessment cannot be performed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re usable instruments be routinely inspected for wear/damage and replaced as necessary.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.We consider this investigation closed.

• Brand Name: TNDM BP SHL/XLPE LNR 44OD 26ID
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 7158382
• MDR Text Key: 96182349
• Report Number: 1020279-2018-00008
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71325044
• Device Lot Number: 17JM10206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention