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

Model Number 1020-1860

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

X-ray right after the tha shows metal piece in the body.Reopen incision.The piece was the tip of impactor.

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 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
• Type of Device: 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
• MDR Text Key: 290533707
• Report Number: 0002249697-2022-00637
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327252910
• UDI-Public: 07613327252910
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention