MAUDE Adverse Event Report: LIMACORPORATE SPA DELTA-TT ACETAB.CUP Ø54 MM; ACETABULAR CUPS (TI6AL4V) DIA. 54MM FOR LINER SIZE LARGE

Model Number 5552.15.540

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/02/2022

Event Type  Injury  

Manufacturer Narrative

The check of sterilization charts did not highlight any pre-existing anomaly on the lot number involved, thus we can state the involved components were regularly sterilized before being placed on the market.A final report will be submitted after the conclusion of the investigations.

Event Description

Hip revision surgery due to infection performed on (b)(6) 2022.The previous surgery took place on (b)(6) 2017.According to the information received, the germ responsible is staphylococcus saccharolyticus.The components involved are the following: mastersl lateralized stem #5 code 351625250 lot 1305852 ster.1500309 (product code not marketed in the usa).Fem.Modular head - m ø32mm code 501042322 lot 1682021 ster.1600336.Delta-tt acetab.Cup ø54 mm for code 555215540 lot 1605068 ster.1600144.Delta protr.Liner øint 32mm #l code 588651160 lot 1706157 ster.1700179.Event occurred in the (b)(6).

Manufacturer Narrative

The sterilization charts of the lot numbers involved were checked with the following results: - no pre-existing anomaly on the 10 master sl lateralized stem #5 code 351625250 lot 1305852 ster.1500309 (product code not marketed in the usa) - no pre-existing anomaly on the 50 fem.Modular head - m ø32mm code 501042322 lot 1682021 ster.1600336 - no pre-existing anomaly on the 50 delta-tt acetab.Cup ø54 mm code 555215540 lot 1605068 ster.1600144 - no pre-existing anomaly on the 50 delta protr.Liner øint 32mm #l code 588651160 lot 1706157 ster.1700179 therefore, we can state that the involved components were regularly sterilized before being placed on the market.X-rays dated 19th october 2021 were shared with limacorporate and analyzed by a medical expert, he commented: "the sent x-rays show a bilateral hip replacement without obvious irregularity.So the reason for revision has been a so called late infection.From the sent history i see that there has been a sudden onset of pain in october 2020, i such presume this has been the time of some hematogenous infection with s.Sacch.This is a very rare pathogen in pji, it most probably should have originated from some enteral disorder.We have seen some similar conditions shortly after covid-vaccination and there are several reports on similar cases.Did the patient receive such vaccine some weeks before onset of symptoms? as this is a low-virulent infection it may be possible that it was discovered only several months later by culturing aspiration fluid.Beside that there is not much to say.The hip must have been removed and replaced either in a single or multiple stage.We use osteomycin v in such conditions." in conclusion, we cannot determine with certainty the cause of the infection reported, however, based on the sterilization charts check and medical analysis performed by our medical consultant, we classify this event as not product related.Pms data based on limacorporate pms data, we estimate a revision rate of the delta tt acetabular cups (family codes 5552.15.Xxx) due to infection of about 0.02%.

Event Description

Hip revision surgery due to infection performed on (b)(6) 2022.The previous surgery took place on (b)(6) 2017.According to the information received, the germ responsible is staphylococcus saccharolyticus.The components involved are the following: - mastersl lateralized stem #5 code 351625250 lot 1305852 ster.1500309 (product code not marketed in the usa) - fem.Modular head - m ø32mm code 501042322 lot 1682021 ster.1600336 - delta-tt acetab.Cup ø54 mm for code 555215540 lot 1605068 ster.1600144 - delta protr.Liner øint 32mm #l code 588651160 lot 1706157 ster.1700179 patient is male, 1.70cm, 84 kg, born on (b)(6)1953.According to the medical history of the patient, he had a spontaneous onset of right groin discomfort in deep flexion on weight bearing in october 2020.Event occurred in the uk.

• Brand Name: DELTA-TT ACETAB.CUP Ø54 MM
• Type of Device: ACETABULAR CUPS (TI6AL4V) DIA. 54MM FOR LINER SIZE LARGE
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 14208123
• MDR Text Key: 290117429
• Report Number: 3008021110-2022-00029
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: 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?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5552.15.540
• Device Lot Number: 1605068
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention