MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +5; FEMORAL SLEEVE

Catalog Number 999800315

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Medical records received.Pc was created to capture for right hip.Increased metal ions.Doi: (b)(6) 2008 dor: unk right hip.Please see (b)(4) for left hip 1st revision.

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy orthopaedics (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(6).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed andthe investigation will be re-opened as necessary.Device history lot
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> device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

Event Description

In addition to what previously alleged, pfs alleges pseudotumor, alval, lack of flexibility and mobility.No revision notes reported.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: ADAPTER SLEEVES 12/14 +5
• Type of Device: FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12923234
• MDR Text Key: 281657335
• Report Number: 1818910-2021-27023
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/18/2021

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 Expiration Date: 07/31/2013
• Device Catalogue Number: 999800315
• Device Lot Number: 2708798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 03/30/2022; 04/22/2022; 08/17/2022
• Supplement Dates FDA Received: 04/01/2022; 04/27/2022; 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2008
• 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
• Treatment: 49 MM LARGE HEAD METAL; 56MM; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; SIZE 8 OFF SET STEM; SUMMIT DUOFIX TAP SZ8 HI OFF; UNK HIP FEMORAL SLEEVE ASR
• Patient Outcome(s): Required Intervention
• Patient Sex: Male