MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 2.0MM 22-13-5 SS CABLE/SLV SET; BONE FIXATION CERCLAGE

Model Number	3704-0-510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a dall miles cable was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: re pi - addendum.This addendum to my report of (b)(6) 2021 includes review of the following additional documentation for this case from (b)(6).(b)(6) 2021 lateral x-ray left hip: hybrid long stem tha, distal stem not visualized, reduced, greater trochanteric non-union with loose cable in fracture site.(b)(6) 2021 implant labels: rest.Mod.Stem 195/21, 21/+30 v40 module, 36/+5 v40 lfit head, 36/10 degree x3 insert, 1 screw, 4 dall-miles cable sets, 2 trochanteric grip plates, 52 trident psl ha cluster shell.Undated labels: #3 exeter cemented long stem, cement restrictor, 35/-5 v40 lfit head, 36/10 degree x3 insert, 1 screw.No revision operative report, no dated serial x-rays, no examination of explanted components.Based upon this additional documentation, neither confirmation of the event description nor preparation of a medical report is possible for this case.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: based upon this additional documentation, neither confirmation of the event description nor preparation of a medical report is possible for this case.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.
Event or Problem Description
Surgeon notified on a case that possibly needed a revision surgery.The surgery was done a few years back using stryker implants.The reason on the revision surgery needed possibly due to aseptic loosening.Per information requested response: "the cable sleeve 3704-0-510 , lot 46496804 was broken prior to surgery.Doctors suspected the cable failure.".

• Brand Name: 2.0MM 22-13-5 SS CABLE/SLV SET
• Common Device Name: BONE FIXATION CERCLAGE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12569398
• Report Number: 0002249697-2021-01666
• Device Sequence Number: 17157296
• Product Code: JDQ
• UDI-Device Identifier: 07613327036374
• UDI-Public: 07613327036374
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K971741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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 Expiration Date: 01/31/2019
• Device Model Number: 3704-0-510
• Device Catalogue Number: 3704-0-510
• Device Lot Number: 46496804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/04/2021
• 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: 75 YR