UNKNOWN SHOULDER HUMERAL STEMS

Additional Manufacturer Narrative

(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

Description of Event or Problem

"THE LITERATURE ARTICLE ENTITLED ¿TREATMENT STRATEGIES FOR INFECTION AFTER REVERSE SHOULDER ARTHROPLASTY¿ BY REINHOLD ORTMAIER; HERBERT RESCH; WOLFGANG HITZL; MICHAEL MAYER; OTTOKAR STUDNER; AND MARK TAUBER; PUBLISHED IN EUR J ORTHOP SURG TRAMATOL ONLINE ON JUNE 8, 2013, WAS REVIEWED. THE ARTICLE¿S PURPOSE WAS TO REPORT ON A RETROSPECTIVE CASE SERIES TO DESCRIBE SPECIFIC TREATMENT STRATEGIES FOR DEEP INFECTION AFTER REVERSE SHOULDER ARTHROPLASTY. DURING A 12-YEAR PERIOD (BETWEEN 1998-2010) 192 PATIENTS (192 SHOULDERS ) WERE TREATED WITH EITHER PRIMARY OR REVISION RSA AT THE AUTHORS¿ INSTITUTION. ALL PROCEDURES WERE PERFORMED BY THREE EXPERIENCED SHOULDER SURGEONS. THE INSTITUTION¿S SHOULDER DATABASE WAS SEARCHED FOR POST-OPERATIVE RSA INFECTION. THERE WERE 21 SHOULDERS IN 21 PATIENTS TREATED FOR DEEP INFECTION AFTER RSA WITH A MINIMUM FOLLOW-UP TIME OF 24 MONTHS. OF THE 21 PATIENTS, ONE PATIENT DIED FROM CAUSES UNRELATED TO THE SHOULDER, WHICH LEFT 20 SHOULDERS IN 20 PATIENTS (95% FOLLOW-UP RATE). ALL 20 PATIENTS HAD INTERVENTIONS DUE TO INFECTION. EACH PATIENT IS BROKEN DOWN WITH SEX, AGE, TREATMENT AND COMPLICATION (IF ANY). " PATIENT 14, (B)(6) MALE, TWO-STAGE REVISION.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. INVESTIGATION METHODS: WAS PATIENT AFFECTED: YES. DEVICE HISTORY REVIEWED: NO. LOT TRACE OBTAINED: NO. COMPLAINTS DATABASE SEARCHED: NO. PRODUCT CHECKED: NO. LABEL CHECKED: NO. PRODUCT PULLED FROM STOCK FOR INSPECTION: NO. A REVIEW OF COMPLAINT DATABASES WAS NOT POSSIBLE AS NO PRODUCT DETAILS WERE RECEIVED. IT SHOULD BE NOTED THAT NO DEVICE WAS RETURNED. WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. POST MARKET SURVEILLANCE IS PER SEP 419. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL.