MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 132 HIP STEM #7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Model Number	6051-0730S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
As reported: "patient had a hemi hip done recently; patient suffered a periprosthetic fracture.Doctor revised the head and stem to a rest mod (with lfit head and uhr bipolar component)." rep confirmed there are no allegations against the revised unitrax head and sleeve, and that no further information will be released by the hospital or surgeon.
Event or Problem Description
As reported: "patient had a hemi hip done recently; patient suffered a periprosthetic fracture.Doctor revised the head and stem to a rest mod (with lfit head and uhr bipolar component)." rep confirmed there are no allegations against the revised unitrax head and sleeve, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a securfit stem was reported.The event was confirmed via medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: this pi which represents a female patient, dob (b)(6) 1927 whose date of implantation is listed as (b)(6) 2020 and explantation (b)(6) 2020.The event description states: ".Semi hip done recently.Periprosthetic fracture.Revision to rest.Mod.Stem and bipolar." undated ap x-ray left hip: uncemented left hemiarthroplasty, reduced with periprosthetic fracture of proximal, medial femur with stem subsidence.(b)(6) implant labels: 44 unitrax head, unitrax c-taper sleeve, #7 secure-fit max stem.(b)(6) implant labels: 155/15 rest.Mod.Stem, 21/0 v-40 body, 28/$ v-40 lfit head, 44 uhr bipolar head.No clinical or pmh, no patient demographics, no operative reports, no post-revision x-rays, no examination of explanted components.While the x-ray and implant labels appear to confirm the event description, insufficient data is presented to create a medical report for this case.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: this pi which represents a female patient, dob (b)(6) 1927 whose date of implantation is listed as (b)(6) 2020 and explantation (b)(6) 2020.The event description states: ".Semi hip done recently.Periprosthetic fracture.Revision to rest.Mod.Stem and bipolar." undated ap x-ray left hip: uncemented left hemiarthroplasty, reduced with periprosthetic fracture of proximal, medial femur with stem subsidence.(b)(6) implant labels: 44 unitrax head, unitrax c-taper sleeve, #7 secure-fit max stem.(b)(6) implant labels: 155/15 rest.Mod.Stem, 21/0 v-40 body, 28/$ v-40 lfit head, 44 uhr bipolar head.No clinical or pmh, no patient demographics, no operative reports, no post-revision x-rays, no examination of explanted components.While the x-ray and implant labels appear to confirm the event description, insufficient data is presented to create a medical report for this case.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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.

• Brand Name: SECUR-FIT MAX 132 HIP STEM #7
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10647855
• Report Number: 0002249697-2020-02069
• Device Sequence Number: 19484335
• Product Code: LZO
• UDI-Device Identifier: 07613327021011
• UDI-Public: 07613327021011
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 05/31/2022
• Device Model Number: 6051-0730S
• Device Catalogue Number: 6051-0730S
• Device Lot Number: 8T77P6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/27/2020
• 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