MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-54E

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Bacterial Infection (1735); Inadequate Osseointegration (2646)

Event Date 09/14/2023

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text : not available.

Event Description

Acetabular hip revision.Primary hip conducted (b)(6) 2021, cup has since loosened and position has changed.Cup was easily removed without the need of an explant.New cup implanted and case completed successfully.

Event Description

Acetabular hip revision.Primary hip conducted (b)(6) 2021, cup has since loosened and position has changed.Cup was easily removed without the need of an explant.New cup implanted and case completed successfully.Update as per med review: a revision acetabulum and femoral head was performed for a loose trident shell.The hip was found to be infected based on intraoperative specimens.The root cause of the revision surgery was a loose acetabular shell.The root cause of the loosening was likely an undiagnosed infection.

Manufacturer Narrative

The following devices were also listed in this report: trident 10° x3 insert 32mm id; cat # 623-10-32e; lot # 8t7lpr.Delta v-40 ceramic head 32/0; cat # 6570-0-132; lot # 86167501.Size 6 accolade ii 132 deg; cat # 6720-0635; lot # 79923107.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding loosening and infection involving a trident shell was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "a revision procedure was performed for a loose acetabular component.The head, shell and liner were revised.The intraoperative specimens showed a staph epi infection.The patient was treated with postoperative antibiotics.No preoperative records, preoperative or intraoperative laboratory results, or post-operative radiographs were provided for review.Only an infection disease note provided postoperatively.Event confirmation: a revision acetabulum and femoral head was performed for a loose trident shell.The hip was found to be infected based on intraoperative specimens.Root cause: the root cause of the revision surgery was a loose acetabular shell.The root cause of the loosening was likely an undiagnosed infection." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: it was reported that the patient was revised due to loosening of the shell.A review of the provided medical information by a clinical consultant indicated: "a revision procedure was performed for a loose acetabular component.The head, shell and liner were revised.The intraoperative specimens showed a staph epi infection.The patient was treated with postoperative antibiotics.No preoperative records, preoperative or intraoperative laboratory results, or post-operative radiographs were provided for review.Only an infection disease note provided postoperatively.Event confirmation: a revision acetabulum and femoral head was performed for a loose trident shell.The hip was found to be infected based on intraoperative specimens.Root cause: the root cause of the revision surgery was a loose acetabular shell.The root cause of the loosening was likely an undiagnosed infection." microbiological assessment was completed by a stryker microbiologist who indicated the following: "staphylococcus epidermidis have been identified as cause of infection of patient.Staphylococcus epidermidis, coagulase-negative staphylococci, have been considered innocuous commensals of human skin and mucous membranes but are now accepted as the leading opportunistic pathogens responsible for numerous nosocomial infections [1].In particular, they account for 30 to 43% of joint prosthesis infections [2].The current accepted pathophysiological mechanism of s.Epidermidis orthopedic device infection is the direct inoculation of skin colonizing strains at the time of surgery [2][3].Stryker can confirm that the origin of infection cannot have been the implants used for this hip surgery.Ultra-high-molecular-weight polyethylene (uhmwpe) plastic hip implants are gamma-irradiated between 25-35kgy for sal 10-6.Metal hip implants are gamma-irradiated between 25-45kgy for sal 10-6.Ceramic hip implants are gamma- irradiated between 25-40kgy for sal 10-6.Uhmwpe plastic x3 hip implants are subjected to overkill sterilisation cycles demonstrating sal 10-6 at half-cycle parameters.Conclusion: due to the nature of the organisms isolated ¿ susceptible to various modes of sterilisation - and the sterilisation methodology employed by stryker, it is not possible that staphylococcus epidermidis could have originated from the implants." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17883912
• MDR Text Key: 325062732
• Report Number: 0002249697-2023-01147
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2024

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: Health Professional
• Device Catalogue Number: 502-03-54E
• Device Lot Number: 38464A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 86 KG