MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TRIAL HEAD DIA 32 #S AND DIA 36 #S; TRIAL HEAD DIA. 32MM S

Model Number 9095.10.721 - 9095.10.731

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No anomaly detected by checking the dhr of the trial femoral heads involved.No other complaint received on the lot number involved, on a total of 54 trial femoral heads ø32mm #s (product code 9095.10.721, lot #201490208) and 54 trial femoral heads ø36mm #s (product code 9095.10.731, lot #201490212) manufactured with the same lot #.We will receive the instruments involved and perform a deeper analysis on this case.To be returned.

Event Description

During different hip replacement surgeries, the connection between the trial femoral heads ø32mm #s and ø36mm #s, and the trial femoral neck appears loose, causing the trial heads to fall out from the trial neck.The malfunction was noticed in more than one surgery, after having performed approximately 28 surgeries with the same instrument set.Surgery time extension of few minutes and no reported consequences for the patient.

Manufacturer Narrative

No anomaly detected by checking the dhr of the trial femoral heads involved.No other complaint received on the lot numbers involved, on a total of (b)(4) trial femoral heads ø32 mm #s (product code 9095.10.721, lot #201490208) and (b)(4) trial femoral heads ø36mm #s (product code 9095.10.731, lot #201490212) manufactured with the same lot #.We received the (b)(4) trial femoral heads involved, together with (b)(4) trial necks used at the hospital involved in combinations with the trial femoral heads.By a visual analysis no sign of deformation or damage can be noticed on the female taper of the trial femoral heads, that is usually connected to the trial femoral neck during surgery.On the other side, some of the male tapers of the trial femoral necks returned show evident signs of damage: indentations can be seen on the male tapers suggesting that they might have been hammered or hit.A dimensional check was performed on the female taper of the (b)(4) trial femoral heads and on the male taper of the (b)(4) trial femoral necks returned to us, and no dimensional anomaly was detected on the undamaged surface of all the pieces.Functional test was performed to assess the stability of the coupling of each trial femoral head with each of the trial femoral neck returned: all coupling showed a good stability, even if some of the trial necks show sign of damage at the taper connection.The above test showed that all the pieces returned are functional.The possible cause of the intra-op issue reported (instability of coupling between trial heads and trial necks) is to be searched on: improper intra-op coupling of the devices; or dirty coupling surfaces when assembling the devices intra-op, which could have prevented a proper coupling.According to our pms data this is the first and only similar complaint received on the trial femoral heads with product code 9095.10.7xx.No corrective actions have been planned for this specific case.Lima corporate will keep monitoring the market on the reoccurrence of this event.

Event Description

During different hip replacement surgeries, the connection between the trial femoral heads ø32 mm #s and ø36 mm #s, and the trial femoral neck appears loose, causing the trial heads to fall out from the trial neck.The malfunction was noticed in more than one surgery, after having performed approximately 28 surgeries with the same instrument set.Surgery time extension of few minutes and no reported consequences for the patient.

• Brand Name: TRIAL HEAD DIA 32 #S AND DIA 36 #S
• Type of Device: TRIAL HEAD DIA. 32MM S
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 5643524
• MDR Text Key: 46214907
• Report Number: 3008021110-2016-00024
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9095.10.721 - 9095.10.731
• Device Lot Number: 201490208 - 201490212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2014
• 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