MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR FEM IMPLANT SZ 46; HIP FEMORAL HEAD

Catalog Number UNK-ASR

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Muscle Weakness (1967); Pain (1994); Discomfort (2330); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Event Description

Litigation papers allege pain, stiffness, discomfort, weakness and excessive metal ion levels.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update 3/29/16 - medical records received.Medical records reviewed for mdr reportability.Revision surgical report noted a failed right hip resurfacing and with reactive tissue and osteolysis of the femoral neck, femoral head and acetabulum.There were no component sticker sheets or lab results within medical records.The complaint was updated on: apr 15, 2016.

Manufacturer Narrative

The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Update 3/28/16 medical records received.Medical records reviewed for mdr reportability.Revision surgical report noted a failed right hip resurfacing and with reactive tissue and osteolysis of the femoral neck, femoral head and acetabulum.There were no component sticker sheets or lab results within medical records.The complaint was updated on: apr 15, 2016.

Manufacturer Narrative

After review of medical records, it was found that this component was not implanted in the patient.This report will be rejected.

Event Description

Update may 05, 2017: legal medical records received.Product and lot number for cup and head were updated.This complaint was updated on: may 8, 2017.

Manufacturer Narrative

The previous medwatch, (b)(4), was sent in error.Please disregard the rejection.The report is still relevant.

Event Description

Update may 05, 2017: legal medical records received.Product and lot number for cup and head were updated.It was discovered that this patient had an asr resurfacing construct.It was discovered that this patient had an asr resurfacing construct.Previously reported unknown asr sleeve and unknown stem products were voided at the medwatch and mdr levels and deleted from this complaint.A void medwatch, (b)(4), for the femoral product was sent in error, but corrected with an additional medwatch follow-up.This complaint was updated on: may 8, 2017.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPUY ASR FEM IMPLANT SZ 46
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 4410510
• MDR Text Key: 5167533
• Report Number: 1818910-2015-10801
• 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: Other,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: UNK-ASR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR