MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-56E

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 12/07/2023

Event Type  Injury  

Event Description

Patient has pain all the time but worse after he sits and stands.He walks with an antalgic gait, and has to use rolling seated walker for ambulation.He has groin pain with internal rotation, external rotation, abduction and adduction.It is alleged that the patient has acetabular component loosening and needs a revision.

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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: PRIMARY TRIT HEMI CLUSTER HOLE CUP 56MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18382353
• MDR Text Key: 331180571
• Report Number: 0002249697-2023-01596
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327040166
• UDI-Public: 07613327040166
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2023

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 502-03-56E
• Device Lot Number: MNH13A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male