MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT ARC/HA COLLAR STEM#6; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number	S-2337-HF06
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
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.Not available.
Event or Problem Description
It was reported that the patient's right hip was revised due to loosening of the femoral stem.The stem, 22 +5 c-taper head, and 36c adm/ mdm poly were revised to a restoration modular stem construct, 22 +0 v40 head, and another 36c adm/ mdm poly.Rep provided an x-ray.Rep also confirmed there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a securfit stem was reported.The event was confirmed via clinician review.Clinician review of the provided x-ray also revealed stem subsidence.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: "undated x-ray: ap right hip demonstrating uncemented tha, reduced, collared stem appears subsided with radiolucent areas in all 7 gruen zones around the stem.  no clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination of explanted components.  while the unlabelled x-ray appears to confirm the event description of a loose femoral stem, insufficient data is presented to create a medical report for this case." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's right hip was revised due to loosening of the femoral stem.Clinician review of the provided unlabelled x-ray appears to confirm the event of a loose femoral stem.It revealed that the "collared stem appears subsided with radiolucent areas in all 7 gruen zones around the stem".The exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot details, return of the device, pathology reports, serial pre- and post-operative x-rays and the 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to loosening of the femoral stem.The stem, 22 +5 c-taper head, and 36c adm/ mdm poly were revised to a restoration modular stem construct, 22 +0 v40 head, and another 36c adm/ mdm poly.Rep provided an x-ray.Rep also confirmed there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.

• Brand Name: SECUR-FIT ARC/HA COLLAR STEM#6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11616065
• Report Number: 0002249697-2021-00605
• Device Sequence Number: 14234222
• Product Code: MEH
• UDI-Device Identifier: 07613327020571
• UDI-Public: 07613327020571
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K941366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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 Model Number: S-2337-HF06
• Device Catalogue Number: S-2337-HF06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR