MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 66MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71338673
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had two-step revision whereby a spacer was implanted on (b)(6) 2015, followed by removal of the spacer and implantation of a new total hip replacement system on (b)(6) 2016.With the exception of the spacer, it has not been possible to confirm precise dates when each component was explanted.A related, previous bhr revision was reported under mdr reference 3005975929-2018-00340.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the clinical information provided, pain, infections, lesions, osteolysis, dislocations, loosening, loss of mobility, loss of strength and metallosis may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.A likely, major contributor to these events is the (methicillin sensitive) staphylococcus intermedius identified, just 3 months post the first revision a review of complaint history on the listed part revealed no prior complaints for the listed batch 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.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.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.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 66MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8279023
• Report Number: 1020279-2019-00292
• Device Sequence Number: 11142092
• Product Code: MBL
• UDI-Device Identifier: 00885556022184
• UDI-Public: 00885556022184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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 Expiration Date: 02/17/2024
• Device Catalogue Number: 71338673
• Device Lot Number: 14BM13839
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71331266/14KITTJ8465; 71332530/15CM01199; 71332540/121M15986; 71332540/14JM17949; 71343612/13EM15954; 71331266/14KITTJ8465; 71332530/15CM01199; 71332540/121M15986; 71332540/14JM17949; 71343612/13EM15954
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR