MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN STRYKER ACCOLADE HIP-SHAFT TMZF 132° 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Degraded (1153); Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The following was reported: "exact date no longer determinable by patient, he has had some pain for some time, but did not pay much attention to it.He rested on a bench a few weeks ago after walking for a long time, did a few knee bends after getting up, then the patient suddenly heard a cracking sound and then almost couldn't walk anymore.Since then existing movement restriction and pain, can only walk short distances.Intraoperatively shows a conus dislocation with conus abrasion: after dissection of the gluteus minimus from the capsule, this opened.Black-greyish fluid discharged from the capsule as metal abrasion and a black membrane was seen.".

• Brand Name: UNKNOWN STRYKER ACCOLADE HIP-SHAFT TMZF 132° 3.5
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17805625
• MDR Text Key: 324114192
• Report Number: 0002249697-2023-01074
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2023

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: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Male