MAUDE Adverse Event Report: ZIMMER GMBH COCR HEAD, XL¸ 36/+8, TAPER 12/14; INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEAD

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331); Toxicity (2333); Reaction (2414)

Event Date 02/07/2013

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review, neither the device has been received for investigation.As no lot numbers were provided for the devices, the device history records could not be reviewed a cause for this specific event cannot be ascertained from the information provided.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

A liability claim was raised.It was reported that the patient was implanted an unknown metal head (catalogue number unknown) on (b)(6) 2008.The patient was revised on (b)(6) 2013 due to loosening, high cobalt chrome levels, metallosis.It was also stated that there was " infection and adverse reaction".

Manufacturer Narrative

Additional information was received on july 11, 2016.Ref and lot number of the devices provided.The evaluation results of the provided information have been made available.Where lot numbers were received for the device, the device history record were reviewed and found to be conforming.Event summary: it was reported that zweymueller stem was implanted on (b)(6) 2008 and revised on (b)(6) 2013 due to pain, loosening, high cobalt chrome levels, metallosis, infection and adverse reaction.Possible root causes: metallosis, aseptic loosening due to excessive wear due to micromotion in taper connection.Possible as the product was not returned for investigation, cannot be excluded.Failure of connection between stem and ball head, metallosis due to fretting corrosion --> wear.Possible as product was not returned for investigation, cannot be excluded.Luxation and wear of components due to insufficient range of motion for components.Possible as no x-rays were received, cannot be excluded.Metal ions in blood due to metal reaction with body fluid , chemical reduction of metals in body fluid.Possible as product was not returned for investigation, cannot be excluded.Excessive wear, disassembly of femoral head from stem, implant failure due to combination with competitor products (off label use).Possible as no other product information received, therefore cannot be excluded.Moreover, no trend on infection has been observed for this product family.Therefore, it is highly unlikely that a disadvantageous product design favored or contributed to the infection.However, the ifu for endoprosthesis d011500200 states that ¿early or late infections¿ are ¿possible consequences of an implant¿ and should be considered when implanting zimmer biomet devices.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant(s) were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, it was impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause could not be determined.Zimmer (b)(4) consider this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: COCR HEAD, XL¸ 36/+8, TAPER 12/14
• Type of Device: INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5649463
• MDR Text Key: 44992062
• Report Number: 0009613350-2016-00667
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.01012.368
• Device Lot Number: 2420698
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR