MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL HEAD - 36MM +0; UNKNOWN HIP IMPLANT

Catalog Number UNK_REC

Device Problem Corroded (1131)

Patient Problem Reaction (2414)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Article http://dx.Doi.Org/10.1016/j.Arth.2015.07.039.The authors reviewed 27 patients who underwent revision for an adverse local tissue reaction (altr) secondary to corrosion at the head-neck junction with metal on uhmwpe bearings.Two of these patients received stryker implants (patient #10 and patient #26).Information specific to the patients implanted with stryker components was not reported in the manuscript.Serum cobalt and chromium levels were elevated in all cases, with a mean cobalt of 11.2 ppb and chromium of 2.2 ppb.Patients underwent modular bearing exchange, including a ceramic head with a titanium sleeve in 23 of 27 cases with only one recurrence of altr in one of the four patients not treated with a ceramic head.

Manufacturer Narrative

An event reporting altr involving an unknown femoral head was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not returned for evaluation.Medical records received and evaluation: a review of the provided journal article was performed by a stryker clinical consultant relating to the patient under the scope of this investigation.The clinician concluded: "in conclusion, this series of 27 patients represents an interesting collection of patients with trunnion problems as still suggested by a large percentage of elevated cobalt levels, suspected taper corrosion and/or potential metal-related altr.There are however too much confounding variables and lack of specific information to draw direct conclusions between the reported facts, findings and metal-related adverse effects many of which have only very soft evidence.All patients underwent revision surgery, mostly by head and/or liner exchange to biolox delta ceramic heads but there is a high likelihood that many reported findings were secondary to other problems many of which may have been procedure-related and/or patient-related.Without much additional information it is not possible to establish a clear principal failure mode for the patients involved including the stryker ones while the likelihood of device-related factors appears very low.In clinical practice, the great majority of arthroplasty trouble that comes to revision has an adverse mix of patient-related factors and/or procedure-related factors regarding suboptimal component position or issues with surgical technique as major underlying problem." conclusions: the exact cause of the event could not be determined because insufficient information was provided.As indicated in the medical review further evidence is needed to confirm the presence of altr.Additional information, including device details,operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Article http://dx.Doi.Org/(b)(4)/j.Arth.2015.07.039.The authors reviewed 27 patients who underwent revision for an adverse local tissue reaction (altr) secondary to corrosion at the head-neck junction with metal on uhmwpe bearings.Two of these patients received stryker implants (patient #10 and patient #26).Information specific to the patients implanted with stryker components was not reported in the manuscript.Serum cobalt and chromium levels were elevated in all cases, with a mean cobalt of 11.2 ppb and chromium of 2.2 ppb.Patients underwent modular bearing exchange, including a ceramic head with a titanium sleeve in 23 of 27 cases with only one recurrence of altr in one of the four patients not treated with a ceramic head.

• Brand Name: UNKNOWN FEMORAL HEAD - 36MM +0
• Type of Device: UNKNOWN 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5451594
• MDR Text Key: 38709520
• Report Number: 0002249697-2016-00484
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

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?: Yes
• 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?: Yes
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• 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