MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 723-00-36D

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Insufficient Information (4580)

Event Date 02/22/2022

Event Type  Injury  

Event Description

Physician performed an i&d with head and liner exchange on a patient that he had originally performed a total hip on (b)(6) 2022.The surgeon expressed that the id of the explanted liner had an unusual appearance.

Manufacturer Narrative

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

Manufacturer Narrative

Reported event: an event regarding infection and wear involving a trident liner was reported.The event was confirmed via visual inspection of the provided photographs of the device and through clinician review of the provided medical records.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that the device has significant damage to the rim in the form of a fractured surface.This damage is consistent with the explantation process.The inner articulating surface of the liner also appears "pitted" or worn.There is blood also visible on the device.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry reports the acute postoperative infection of a total hip replacement about 1 month after surgery.It also reports ¿pitting¿ of the acetabular liner.I can confirm that this event took place since i was able review the operation notes and examine the explanted implants.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of immediate post op infection are multifactorial including contamination at the time of surgery and seeding from a remote infection source.Pitting of an x3 liner at any time is quite unusual but at 4 weeks is perplexing.Causes could include third body wear.The liner would have to undergo biomedical examination to determine exactly what the issue is." -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 infection and that "pitting" was observed on the liner during the revision procedure.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that the device has significant damage to the rim in the form of a fractured surface.This damage is consistent with the explantation process.The inner articulating surface of the liner also appears "pitted" or worn.There is blood also visible on the device.A review of the provided medical information by a clinical consultant indicated: "this inquiry reports the acute postoperative infection of a total hip replacement about 1 month after surgery.It also reports ¿pitting¿ of the acetabular liner.I can confirm that this event took place since i was able review the operation notes and examine the explanted implants.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of immediate post op infection are multifactorial including contamination at the time of surgery and seeding from a remote infection source.Pitting of an x3 liner at any time is quite unusual but at 4 weeks is perplexing.Causes could include third body wear.The liner would have to undergo biomedical examination to determine exactly what the issue is." a microbiological assessment was completed by a stryker microbiologist who indicated: "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 tha surgery.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.X3 hip implants are subjected to overkill gas-plasma hydrogen peroxide 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 probable that staphylococcus epidermidis could have originated from the implants." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Catalog numbers and lot codes of other devices listed in this report: 702-04-50d tridentii tritanium cluster50d trident ii tritanium 50 mm acetabular shell lot 88169001a 6570-0-236 delta v-40 ceramic head 36/+5 biolox delta ceramic v40, 36 mm +5 femoral head lot 89287403 6721-0230 size 2 accolade ii 127 deg accolade ii size 2, 127-degree neck angle hip stem lot 83243802 7030-6530 6.5mm low profile hex screw 30mm 6.5 mm low-profile hex screw lot z3hh it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Physician performed an i&d with head and liner exchange on a patient that he had originally performed a total hip on (b)(6) 22.The surgeon expressed that the id of the explanted liner had an unusual appearance.Update (b)(6) 2022: provided medical records indicated that the patient was revised due to wound drainage, dehiscence, and infection (staphylococcus epidermidis).Right hip.

• Brand Name: TRIDENT 0 DEG INSERT 36MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13824615
• MDR Text Key: 288118714
• Report Number: 0002249697-2022-00413
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327296990
• UDI-Public: 07613327296990
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2022

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 Model Number: 723-00-36D
• Device Catalogue Number: 723-00-36D
• Device Lot Number: D66ET9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 82 KG