MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Test Result (2695); No Code Available (3191)

Event Date 07/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Literature article received entitled "no difference in re operations at 2 years between ceramic-onmetal and metal-on-metal tha: a randomized trial".Literature article entitled, "no difference in reoperations at 2 years between ceramic-on-metal and metal-on-metal tha: a randomized trial" by c.Anderson engh jr.Md, et al, published in clinical orthopaedics and related research (2 july 2015) by the association of bone and joint surgeons, vol.474, pp.447-455 was reviewed for mdr reportability.This trial reviews the postoperative revision rates of patients receiving 194 com and 196 mom primary thas between august 1, 2005 and october 31, 2006 over a minimum two-year follow-up.All patients received the same depuy pinnacle titanium acetabular, acetabular cup with self locking taper and cocrmo metal liner.196 cocrmo femoral heads and 194 biolox delta ceramic heads were used.There were 94 cocr porous coated cylindrical aml or prodigy, 202 ti summit dual-taper, 94 ti proximally coated modular s-rom femoral stem implants in this study.The researchers collected blood to evaluate serum ion levels preoperatively and at 12-, 24-, and 60 month intervals during the postoperative period.54% of the participants were female and 57% were male with a mean age of 59-60 and bmi of 30.In the mom group, there were 4 revision surgeries unrelated to the bearing surfaces: 1 hematoma evacuation at 7 days post-op, 1 dislocation at 4 months, 1 infection at 9 months, and one fractured femoral component at 44 months.There were 2 revisions related to the bearing surfaces.The first patient presented with pain, adverse local tissue reaction, and elevated blood heavy metal 44 months postoperatively with the liner and head revised.The second patient presented with squeaking in the operative hip, and severely elevated serum ions; the head and the liner were revised.In the mom group, all patients had some elevated serum ions varying in severity and one patient showed radiography evidence of femoral osteolysis that did not require revision.In the com group there were three revisions: 1 hematoma evacuation at 2 weeks, 1 infection at 23 months, and one heterotopic ossification excision at 33 months.There were no revisions related to the acetabular bearing surface issues.1 patient had radiographic evidence of femoral osteolysis and most patients had some degree of elevated serum ions.The com group lost one patient to death that was unrelated to the tha surgery or any implant component.The authors concluded that mom bearing surfaces have a greater likelihood of increasing serum co and cr levels over time than com bearings.The authors did not identify specific harms with specific products.All adverse events are captured within the event description and each component.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8961281
• MDR Text Key: 161202577
• Report Number: 1818910-2019-102849
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention