MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-60F
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient, that he was implanted with a right stryker hip on (b)(6) 2018.The patient alleges in or about (b)(6) 2018 he started to experience excruciating pain and couldn¿t put weight on his hip.The patient followed up with his primary surgeon and was diagnosed with bursitis.The patient continued to experience pain and stated he has seen multiple doctors.Allegedly in 2021 the patient went for a second opinion and the surgeon performed a radiolucency test and told the patient the acetabular cup was loose and revision surgery was recommended.The patient was revised (b)(6) 2021.The patient is seeking compensation for his pain and suffering.
Additional 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 or Problem Description
It was reported by the patient, that he was implanted with a right stryker hip on (b)(6), 2018.The patient alleges in or about (b)(6) 2018 he started to experience excruciating pain and couldn¿t put weight on his hip.The patient followed up with his primary surgeon and was diagnosed with bursitis.The patient continued to experience pain and stated he has seen multiple doctors.Allegedly in 2021 the patient went for a second opinion and the surgeon performed a radiolucency test and told the patient the acetabular cup was loose and revision surgery was recommended.The patient was revised (b)(6) 2021.The patient is seeking compensation for his pain and suffering.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving trident shell was reported.The event was not confirmed.Method & results:  device evaluation and results: not performed as product was not returned.  clinician review: no medical records were received for review with a clinical consultant.Device history review: review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion:  the root cause could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM
• Common Device Name: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16156337
• Report Number: 0002249697-2023-00041
• Device Sequence Number: 12630077
• Product Code: LPH
• UDI-Device Identifier: 07613327040173
• UDI-Public: 07613327040173
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 502-03-60F
• Device Catalogue Number: 502-03-60F
• Device Lot Number: 970M4H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 97 KG