MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIGH OFFSET NEUTRAL MODULAR NECK; PROSTHESIS,HIP,SM-CNSTRND,MTL/PLYMR,PROS UNCMNTD

Model Number	71352112
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had infection of prosthetic hip joint and liner, head and neck were exchanged.Stem was still implanted and there was a dull revision of the acetabulum.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this complaint from the redapt clinical study reports the revision of a hip secondary to an ¿infection of the prosthesis¿; the shell, liner, neck and head were exchanged.The study report states this event as not related to the prosthesis and possibly related to the procedure.No clinical/medical documentation was provided for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Infection is a complication that can be associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: HIGH OFFSET NEUTRAL MODULAR NECK
• Common Device Name: PROSTHESIS,HIP,SM-CNSTRND,MTL/PLYMR,PROS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9448483
• Report Number: 1020279-2019-04363
• Device Sequence Number: 2210140
• Product Code: LPH
• UDI-Device Identifier: 03596010619549
• UDI-Public: 03596010619549
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 71352112
• Device Catalogue Number: 71352112
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 04/14/2020
• 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