MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT TRIAL BODY SZ 16 +; PROSTHESIS,HIP,SEMI-CONSTR.,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS,UNCEM.

Catalog Number 71354632

Device Problems Retraction Problem (1536); Use of Device Problem (1670); Positioning Problem (3009)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 03/23/2017

Event Type  Injury  

Event Description

It was reported that the extraction hole is placed to low and that additional bone had to be removed to access the extraction hole of the body.

Manufacturer Narrative

(b)(4).

• Brand Name: REDAPT TRIAL BODY SZ 16 +
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTR.,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS,UNCEM.
• 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 ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6503216
• MDR Text Key: 73116912
• Report Number: 1020279-2017-00279
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71354632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability