MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR OFFSET QUICK CONNECT INSERTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1020-1860
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
X-ray right after the tha shows metal piece in the body.Reopen incision.The piece was the tip of impactor.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an accolade inserter was reported.The event was confirmed via evaluation of the returned device and clinician review of provided x-ray.Method & results: product evaluation and results: visual inspection of the returned device was performed as part of the material analysis: a material analysis was performed and concluded the following: "review of modular offset quick connect inserter, catalogue # 1020-1860, lot code sc22580 confirmed fracture of inserts from the inserter end fitting.Characterisation using stereo microscopy and scanning electron microscopy confirmed the returned insert fractured due to overload.Mechanical damage was observed on all sides of the component.No manufacturing or material related defects were observed on the device surfaces examined.".Clinician review: a review of the provided medical records by a clinical consultant indicated the following: "the post operative x-ray documents that a linear metallic radiopaque foreign body is present in the lateral thigh.[.] it is confirmed that a foreign body was present on the post-operative x-ray.No information was provided documenting revision surgery to remove the fragment.The root cause of this event cannot be determined from this limited information.".Product history review: review of the device history records indicate devices were manufactured and accepted into final stock between with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported that the post-operative x-ray showed a metal fragment in the patient resulting from the fracture of an accolade inserter.It was further reported that the wound was reopened to remove the fragment.A review of the provided medical records by a clinical consultant indicated the following: "the post operative x-ray documents that a linear metallic radiopaque foreign body is present in the lateral thigh.[.] it is confirmed that a foreign body was present on the post-operative x-ray.No information was provided documenting revision surgery to remove the fragment.The root cause of this event cannot be determined from this limited information." a material analysis was performed on the returned device and concluded the following: "review of modular offset quick connect inserter, catalogue # 1020-1860, lot code sc22580 confirmed fracture of inserts from the inserter end fitting.Characterisation using stereo microscopy and scanning electron microscopy confirmed the returned insert fractured due to overload.Mechanical damage was observed on all sides of the component.No manufacturing or material related defects were observed on the device surfaces examined." 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
X-ray right after the tha shows metal piece in the body.Reopen incision.The piece was the tip of impactor.

• Brand Name: MODULAR OFFSET QUICK CONNECT INSERTER
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14266055
• Report Number: 0002249697-2022-00637
• Device Sequence Number: 5907406
• Product Code: LPH
• UDI-Device Identifier: 07613327252910
• UDI-Public: 07613327252910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 1020-1860
• Device Catalogue Number: 1020-1860
• Device Lot Number: SC22580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown