MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CEMENTLESS MINI STEM; SMR CEMENTLESS MINI STEM (HSD-KWT)

Model Number 1304.15.130

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved lot#s, no pre-existing anomaly was detected.This is the first and only complaint due to infection on these lot#s.We will submit a final mdr once the investigation will be concluded.

Event Description

Revision surgery performed on (b)(6) 2020 due to pain and suspected infection.Previous surgery was performed on (b)(6) 2012.During revision surgery, all the implants were removed as per surgical technique and replaced with zimmer antibiotic spacer.Following, the explanted implants are reported: 1304.15.130, smr cementless mini stem , lot #1010159, ster.1100191; 1352.15.050, smr reverse finned humer.Body, lot #1111271, ster.1100361; 1374.09.105, smr glenosphere ø36mm small-r, lot #1112532, ster.1100383; 8420.15.010, bone screw ø6,5 h.20mm, lot #1114221, ster.1200030; 8420.15.010, bone screw ø6,5 h.20mm, lot #1200118, ster.1200038.No other information available.Event occurred in (b)(6).

Event Description

Revision surgery of smr reverse prosthesis performed on (b)(6) 2020 due suspected infection.Pain was also reported.Previous surgery was performed on (b)(6) 2012.During the revision surgery, all the implants previously implanted were removed as per surgical technique and replaced with a competitor antibiotic spacer.Germ responsible for the infection is unknown.Following, the explants product informations are reported: product code 1304.15.130, smr cementless mini stem, lot #1010159, ster.1100191 product code 1352.20.010, smr reverse humeral body, not marked in usa,, product code 1360.50.010, smr reverse liner standard, lot #1109687, ster.1100335 product code 1374.09.105, smr glenosphere ø36mm small-r, lot #1112532, ster.1100383, product code 1375.25.050, cementless glenoid small-r, not marked in usa, product code 8420.15.010, bone screw ø6,5 h.20mm, lot #1114221, ster.1200030, product code 8420.15.010, bone screw ø6,5 h.20mm, lot #1200118, ster.1200038.No other information available.Event occurred in australia.

Manufacturer Narrative

By checking the sterilization charts of the involved lots, no pre-existing anomaly was found on the overall number.Therefore, we can ensure that all the products placed on the market with these lots have been properly sterilized before being placed on the market.This is the first and only complaint received on these lots/ster.We received a picture of the explanted items + a single x-ray image referring to pre-op revision surgery (no exact date).We asked for a clinical judgment of the case to our medical consultant.Following, his comments: "the implant has survived eight years so if infected it is likely to be blood borne rather than from contamination at the time of surgery.Also i suspect the patient is female because the humeral stem is one of the extra small 12/13 mm.The significance being there is a higher incidence of cutibacterium acnes in males which is usually considered caused by local contamination rather than blood borne.The films are of insufficient quality to comment on evidence of infection.The only comment i can make regarding the xray is that the glenoid baseplate is high in the glenoid fossa which has caused impingement and this can be seen on the explanted poly implant.There is no peer reviewed evidence but i have always felt that impingement may be a risk factor in infection.In summary all we can say is that late infection has occurred.There is evidence of impingement because of a technical error in positioning the glenoid baseplate.There is no evidence that this will have caused or increased the risk of infection".From the info received by complaint source, patient involved in this case was a female.Based on the analysis performed and by our medical consultant's opinion, we can state that this late infection case was mostly related to a technical error in positioning the glenoid baseplate during the previous surgery.Complaint not product related.Pms data.Revision rate associated to infection of smr reverse prosthesis = 0,06%.No corrective actions performed for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

• Brand Name: SMR CEMENTLESS MINI STEM
• Type of Device: SMR CEMENTLESS MINI STEM (HSD-KWT)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9611201
• MDR Text Key: 189635044
• Report Number: 3008021110-2020-00002
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

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
• Device Operator: No Information
• Device Model Number: 1304.15.130
• Device Lot Number: 1010159
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention