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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Hematoma (1884); Necrosis (1971); Joint Dislocation (2374)
Event Date 12/07/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: zimmer cat# 01. 06010. 306 avenir stem lat cemented 6 lot# 3039253; zimmer cat# 00500105200 shell 52 mm o. D. Lot# 64892224. Report source: foreign country: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03693.
 
Event Description
It was reported that patient underwent a left hip arthroplasty. Subsequently, the patient was revised approximately 2. 5 weeks later due to dislocation. It is believed that the original femoral component was cemented too proud. The patient hip joint was believed to be too tight. It was revised to a smaller size stem and placed with more anteversion. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: zimmer cat# 01. 06010. 306 avenir stem lat cemented 6 lot# 3039253; zimmer cat# 00500105200 shell 52 mm o. D. Lot# 64892224. Report source: foreign country: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03693.
 
Event Description
It was reported that patient underwent a left hip arthroplasty. Subsequently, the patient was revised approximately 2. 5 weeks later due to dislocation. It is believed that the original femoral component was cemented too proud. The patient hip joint was believed to be too tight. It was revised to a smaller size stem and placed with more anteversion. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameLINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13110858
MDR Text Key285184882
Report Number0002648920-2021-00461
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K833991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00500105028
Device Lot Number64892224
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/29/2021 Patient Sequence Number: 1
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