MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LINER; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Material Discolored (1170); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333); Injury (2348); Ambulation Difficulties (2544)

Event Date 03/10/2015

Event Type  Injury  

Event Description

Surgeon reports patient a status post left total hip replacement has dislocated twice, has pain in the hip, mri show fluid collection and lab work shows elevated levels of cobalt.Surgeon decided to revise the hip through the posterior approach.He noted upon entering the joint space a large amount of dark fluid came out.He also noted the dark discoloration of the surrounding tissues.After dislocating the hip he carefully removed the 36mm +10 metal head.He noted the trunnion to be covered in a black substance.It was noted that the existing stem and cup were well fixed in the bone.He carefully removed the 36 liner.After cleaning out the suspect tissue around the cup he re-implanted a new eccentric liner.He then 16307-50011 cleaned the trunnion placed a titanium v40 to c taper sleeve over the trunnion and impacted a new 36 +7.5 c-taper delta biolox head.The hip was reduce.An existing cable was removed and the surgical site was closed.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown liner.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Sent to pathology for patient pickup.

Manufacturer Narrative

Conclusion: clinician review of the x-rays confirms the dislocation.However, additional records such as surgery histology, specific cobalt chromium levels, operative reports, and material analysis of the devices and mri are needed to determine the root cause of the reported event.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Surgeon reports patient a status post left total hip replacement has dislocated twice, has pain in the hip, mri show fluid collection and lab work shows elevated levels of cobalt.Surgeon decided to revise the hip through the posterior approach.He noted upon entering the joint space a large amount of dark fluid came out.He also noted the dark discoloration of the surrounding tissues.After dislocating the hip he carefully removed the 36mm +10 metal head.He noted the trunnion to be covered in a black substance.It was noted that the existing stem and cup were well fixed in the bone.He carefully removed the 36 liner.After cleaning out the suspect tissue around the cup he re-implanted a new eccentric liner.He then 16307-50011 cleaned the trunnion placed a titanium v40 to c taper sleeve over the trunnion and impacted a new 36 +7.5 c-taper delta biolox head.The hip was reduce.An existing cable was removed and the surgical site was closed.

• Brand Name: UNKNOWN LINER
• Type of Device: HIP IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4654377
• MDR Text Key: 16628502
• Report Number: 0002249697-2015-01050
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 86